Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case!
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Add Photo/Video
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Endologix® Inc. Ovation iX Stent Graft system - recalled due to material weakness, United States

3 years ago

United States

Company name: Endologix® Inc.
Brand name: Ovation
Product recalled: Ovation iX system
Reason of the recall: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.
FDA Recall date: July 08, 2020
Recall details: Company Announcement Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed. Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related. All lots/serial numbers, not yet implanted, of the following models are in the scope of the correction:
Check the full recall details on fda.gov
Source: FDA

303


Related Reports

InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the... See More Nimbus Infusion Pump systems dated May 2019 to August 2023.

Evaluation of complaint data has identified several potential product issues:
- Battery Power may potentially affect the performance of the pump by causing an immediate power off event.
- Upstream Occlusion, as noted by the upstream occlusion alarm, occurs when there is a block in flow of the proximal end of the administration set.
- System Errors, as noted by the System Error alarm which causes the pump to suspend the infusion.
- Drug product egress from certain administration set bonding points, which may potentially result in drug product leaking from the device.
- Flow Rate (high or low) which may potentially lead to the pump infusing an inaccurate delivery of the drug.
- Pump Housing design which may potentially result in damage over time to certain areas of the housing responsible for administration set engagement, leading to false occlusions and flow rate inaccuracies.

These product issues were identified through the InfuTronix post-market surveillance system and evaluated through the InfuTronix Corrective Action/Preventive Action (CAPA) system. InfuTronix has determined that the best corrective and preventive action to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system. The redesign of the system will allow InfuTronix to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set. Given the number of anticipated design improvements and the extensive requirement for design, verification, and validation, InfuTronix believes a new premarket notification(s) and clearance from FDA may be required. As such, InfuTronix is seeking to remove the system from the market while these improvements and design changes are being made and a new clearance(s) is obtained.

A health hazard evaluation (HHE) was performed by an independent physician to evaluate routine post-market complaint failure modes associated with the Nimbus family of infusion pumps. The HHE determined that the common device failure modes pose a low risk to users.

The Nimbus Infusion Pump system has been distributed throughout the United States since October 17, 2014 until February 21, 2024. It has never been distributed internationally. Affected devices have the following Unique Device Identification numbers associated with them:
- Nimbus Ambulatory Infusion Pump 00817170020000
- Nimbus II PainPRO 00817170020086
- Nimbus II Flex 00817170020093
- Nimbus II Plus 00817170020161
- Nimbus II EpiD 00817170020376
- Nimbus II EMS 00817170020109

Users may continue to use the Nimbus Infusion Pump system and associated infusion sets during this removal process. Users should be aware of the signs indicating a potential issue with the pump (How to recognize that a device may fail):

- Battery – The infusion pump will brown out (fail-safe). The user will see that the pump has shut off. Additionally, the LED screen may flicker prior to failure, indicating a potential battery issue.
- Upstream Occlusion - Auditory and visual occlusion alarm alerts the user of the occlusion.
- System Error - Auditory and visual system error alarm will alert the user.
- Drug Product Egress – The user may notice leaking drug from the pump pouch or infusion set or feel wetness from the drug product.
- Flow Rate (high/low) - Auditory and visual occlusion alarm for low flow will alert the user of occlusion. The user will notice residual volume remaining at the end of therapy. High flow rate may be associated with shortened infusion times.
- Pump Housing Damage - The user may notice broken latches, hinges, or cracks in the housing and/or user may notice that the device is difficult to assemble prior to use.

Infutronix has already notified customers with a letter that details the products impacted, reason for the voluntary removal, risk to health assessment, how to recognize the device may fail and actions to be taken by the customer/user.

The continued use of the Nimbus Infusion Pump system and associated infusion sets is safe during this removal process. Users should be aware of the signs indicating a potential issue with the pump as described above, “How to recognize that a device may fail”. As with any use, health care providers (HCPs) should read the Instructions for Use (IFU) and follow those closely to ensure proper performance of the pump with its associated accessory set. Further, HCPs should educate patients on proper use of the pump and accessories, and potential operational concerns. As a reminder to HCPs,

- When replacing batteries, only new batteries should be used. Care should be taken to ensure that old and new batteries are not confused when completing the replacement. When resetting the battery state, HCPs are encouraged to pay close attention to the device indicator lights and LED screen indicating battery life.
- HCPs should take care to clear an occlusion alarm properly. The battery should not be cycled (turned on/off) to clear the occlusion alarm. If the occlusion alarm cannot be cleared, a new pump should be used. Patients should be educated that silencing the alarm does not clear the occlusion.
- Due to the potential ambulatory use of the pump, patients may carry the drug product dispensing pouch in a carrying pack. Patients should be educated that impeding the tubing set or placing pressure on the device (leaning against it, sitting on it) may cause the device to malfunction.
- HCPs are encouraged to educate patients on potential drug leakage and establish appropriate containment protocols for users to follow.

HCPs should ensure users are educated to recognize audio and visual alarms and inspect their device for damage. Any difficulties or abnormalities noted with the pump or accessories should result in immediate discontinued use of the pump and notification to the HCP. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service, where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning both the Nimbus Infusion Pumps and associated infusion sets.

Customers who purchase the Nimbus Infusion Pump and/or associated infusion sets from a distributor should contact their distributor directly and receive instructions on the RMA process to be followed. As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient’s needs, based on their medical expertise, at the earliest possible opportunity. InfuTronix is removing the Nimbus Infusion Pump Systems from the market.

The products will no longer be supported by InfuTronix for either Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. To return Nimbus products customers should follow the instructions provided in the Medical Device Removal letter that was sent by InfuTronix, contact InfuTronix customer service or their local distributor.

Company name: InfuTronix, LLC
Brand name: Nimbus
Product recalled: Nimbus Pump System
Reason of the recall: Recall due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systems
FDA Recall date: March 20, 2024

Source: fda.gov
See Less
303


On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or... See More the position of the implant, potentially resulting in serious injury or death. Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets.

Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.

Sleepnet masks with magnets are safe when used in accordance with the newly updated Instructions for Use. Continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Sleepnet is adding a new contraindication and an updated warning to the Instructions for Use labeling of the affected products. This will be included in the labeling for all future production of these masks. The labeling will be updated to state the following:
1- New Contraindication:
Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs , torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.

2- Updated Warning:
Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

If a patient, or anyone in close physical contact, has an active medical implant or metallic implant, they should contact their mask supplier to find a replacement mask that does not include magnets. If the patient is unsure whether or not they should use the mask, they should consult their physician or the manufacturer of their implant.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Sleepnet Corporation
Brand name: Mojo, Mojo 2, iQ 2, Phantom 2
Product recalled: CPAP and BIPAP Masks with Magnets
Reason of the recall: Potential interference with certain medical implants
FDA Recall date: March 18, 2024

Source: fda.gov
See Less
303


Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA... See More SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.

Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024

Recall link of December 2023: jnjmedtech.com
Source: fda.gov
See Less
303


Avanos Medical, Inc. voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. This recall initiated in direct response to... See More the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products which was promtpted due to concerns about the potential lack of sterility assurance. Avanos has not been directly contacted with any reported adverse events.

This deficiency may lead to non-sterile products, posing a risk of the water coming into contact with a patient’s surgical site. Any open wound exposed to non-sterile products could potentially put the patient at risk of infection. The pre-filled syringe is the only item in the Avanos feeding tube kit affected by the Nurse Assist recall.

As of Feb. 6, 2024, the FDA reported receiving adverse events associated with use of Nurse Assist products and is further evaluating this information.

Upon evaluating the impact of the Nurse Assist recall, Avanos has identified the affected MIC* Gastric – Jejunal Feeding Tube Kit product codes and lot numbers. Customers receiving the listed lots are instructed to remove all affected kits from facilities and requested to take the following actions:

- Continue normal post-op care for any newly placed MIC* GJ tube.
- Report any adverse events involving these products immediately.
- Check all storage facilities and warehouse locations for affected products and quarantine them.
- Destroy all affected lots in inventory.
- Notify other departments or customers of this recall.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Avanos Medical, Inc.
Brand name: Avanos Medical
Product recalled: MIC* Gastric-Jejunal Feeding Tube Kits
Reason of the recall: Potential Lack of Sterility Assurance
FDA Recall date: February 27, 2024

Source: fda.gov
See Less
303


Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and... See More trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product. There have been no reports of patient harm.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, which you can see in the link below. Customers who received the listed lots were given instructions to:
1. QUARANTINE affected kits/trays.
2. ALERT clinicians of the recalled component(s).
3. AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).
4. NOTIFY other departments, facilities or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgement form to them.
5. RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Expanded list of Urology and OR room specific kits and trays
Reason of the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: February 05, 2024

Source: fda.gov
See Less
303


Ordered a pillow in November 28 2022. Took my money and never received my product. Now they refuse to answer my p.m or emails. See Less


with email bonjourjen@outlook. com
I experienced scam. I ordered Uggs women's Designer Sandals from Nordstrom Rack, which was advertised on Instagram and I never received the items. Do not open any links from this email when they send you email confirmation for your purchase - here is... See More the email.
service @nordstromvip. shop
See Less


I finally received a torch I ordered many months ago. It was sold as an all electric plasma torch that did not need fuel of any sort. What I got was a poor quality butane lighter. Total fraud.

From Tech 1 (US) 192 Northern Blvd. Flushing NY 11358 See Less


I received merchandise from this company, with no return slip. I did not order from them. I ordered from Hatmeo. They did not say they were an overseas company Xentai Tech Limi Hong Kong Airwalle. To many companies. I need a return slip or a refund. See Less


Recent Interesting Reports

I have been trying to stop these from coming and billing there is no invoice or email or phone to contact. I have put a stop payment for any future billings. This is a scam and there is no contact information See Less
1.4K


Never ordered anything from the alleged seller/scammer. Package is cake box size and weighty. Did not open it. Could be anything in there, including harmful stuff. Checking cards to see if someone illegally charged me. Reporting this as a fraud and scam by the alleged unnamed "online... See More seller" at 3646 S. Wolcott Ave., Chicago, Il, 60609. I demand law enforcement do a P Diddy type raid on this place and bring these scammers down now!!

Very suspect.
See Less


9400 1112 0621 7034 292**** barcode of this unordered product
Like few others, I have also received this unordered package containing this jar with a powder See Less
272


I received the wrong order from your company and would like a refund for what I did receive which was a hairpiece with no bangs. What I ordered was a hairpiece with bangs. The price was $22.98 with shipping and handling $4.99. The total cost and refund... See More should be $27.97. My order number is 03920671****. See Less
12


I bought a package for 48 USD for electronic merchandise, which according to the promotion was from Amazon. When I received the email in my inbox it was from that entity; www.zebra-internet-net. I followed the shipment and was redirected to a page in China that gave me... See More a record of the shipment with the order number. I am outraged, she informs me that it was delivered to me on March 11 at the address I gave and NOTHING ever arrived to me. Unfortunately, that's a lot of money here. I sent him several emails for the refund and they never answered me. - See Less
1


Last 30 days