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Boston Scientific Corporation LOTUS Edge™ Aortic Valve System - recalled due to Delivery System Issues Potential inability to release the delivery system, USA

3 years ago

United States

Company name: Boston Scientific Corporation
Brand name: LOTUS Edge™ Aortic Valve System
Product recalled: LOTUS Edge™ Aortic Valve System
Reason of the recall: Delivery System Issues Potential inability to release the delivery system
FDA Recall date: January 11, 2021
Recall details: Boston Scientific Corporation (NYSE: BSX) has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant. There is no safety issue for patients who currently have an implanted LOTUS Edge valve.

Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire LOTUS product platform immediately. All related commercial, clinical, research & development and manufacturing activities will also cease.

"While we have been pleased with the benefits the LOTUS Edge valve has provided to patients, we have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform. We will instead focus our resources and efforts on our ACURATE neo2™ Aortic Valve System, Sentinel™ Cerebral Embolic Protection System and other high growth areas across our portfolio."

This decision is expected to result in estimated total pre-tax GAAP charges of approximately $225 million to $300 million due to inventory, fixed asset, intangible asset and certain other exit charges and approximately $100 million to $150 million of these charges will impact the company's adjusted results. The vast majority of these charges will be recorded during the fourth quarter of 2020. The decision is expected to be accretive to GAAP and adjusted earnings per share in 2021 by approximately one to two cents and neutral thereafter. Conference Call and Webcast Information Boston Scientific will be hosting a conference call for investors on November 17, 2020 at 8:00 a.m. EST to discuss the announcement. To participate in the conference call, please dial (833) 685-0550 or (412) 317-5733. The live webcast and archived replay of this call will be available at our Investor Relations website investors.bostonscientific.com in the Events section.

Check the full recall details on fda.gov

Source: FDA

303


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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
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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.

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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.

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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.
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Recall link of December 2023: jnjmedtech.com
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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.

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