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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Medtronic Valiant Navion™ Thoracic stent graft system - recalled due to endoleaks, stent fractures and stent ring enlargement, USA

4 years ago •source fda.gov • details

Company name: Medtronic
Brand name: Medtronic Valiant Navion™
Product recalled: Thoracic stent graft system
Reason of the recall: Due to endoleaks, stent fractures and stent ring enlargement
FDA Recall date: February 23, 2021
Recall details: Medtronic plc (NYSE:MDT), the global leader in medical technology, has voluntarily issued… See more

#medicaldevices #recall #unitedstates

312   Comments Comment

Recall notice

Wahl Clipper Deluxe Heat Therapy Massagers - recalled due to fire hazard, USA

4 years ago •source fda.gov • details

Company name: Wahl Clipper Corporation
Brand name: Wahl
Product recalled: Deluxe Heat Therapy Massagers, Model 4212
Reason of the recall: Can overheat causing smoke or spark, which may pose a fire hazard
FDA Recall date: January 28, 2021
Recall details: Wahl Clipper Corporation is voluntarily recalling all… See more

#medicaldevices #unitedstates

Recalls Wahl Clipper Deluxe Heat Therapy Massagers - recalled due to fire hazard Company name: Wahl Clipper... photo #1
312   Comments Comment

Recall notice

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

5 years ago •source fda.gov • details

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… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

Sigma Spectrum Infusion Pumps - recalled due to deviations from the specified cleaning methods may impair infusion pump, USA

5 years ago •source fda.gov • details

Company name: Baxter International Inc.
Brand name: Sigma Spectrum
Product recalled: Infusion Pumps
Reason of the recall: Deviations from the specified cleaning methods may impair infusion pump
FDA Recall date: October 29, 2020
Recall details: Baxter International Inc. announced today it has issued an Urgent Device Correction… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

BD Alaris System Hardware - recalled due to Potential for four hardware situations that may result in the infusion pump not operating as expected, USA

5 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: BD Alaris System Hardware
Reason of the recall: Potential for four hardware situations that may result in the infusion pump not operating as expected
FDA Recall date: September 21, 2020
Recall details: Three Recalls Designated as… See more

#medicaldevices #recall #unitedstates

312   Comments Comment

Recall notice

Alaris Infusion Pump - recalled due to Hardware issues may cause the infusion pump to not operate as expected, USA

5 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: Alaris Infusion Pump
Reason of the recall: Hardware issues may cause the infusion pump to not operate as expected
FDA Recall date: September 01, 2020
Recall details: Majority of June 30 Recall Designated as Class I… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

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

5 years ago •source fda.gov • details

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)… See more

#medicaldevices #unitedstates

312   Comments Comment

Recall notice

Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potentially could cause over-infusion or under-infusion of therapy, USA

5 years ago •source fda.gov • details

Company name: CME America
Brand name: BodyGuard
Product recalled: Infusion System Administration Set (infusion set)
Reason of the recall: Use of the pump system potentially could cause over-infusion or under-infusion of therapy
FDA Recall date: July 08, 2020
Recall details: PRNewswire/ - CME America, a wholly owned… See more

#medicaldevices #unitedstates

Recalls Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potential... photo #1
312   Comments Comment

Recall notice

Chengdu Ai Qin Colored contact lenses - recalled due to being distributed without FDA clearance, USA

5 years ago •source fda.gov • details

Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
Product recalled: Colored contact lenses
Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated… See more

#medicaldevices #unitedstates

Recalls Chengdu Ai Qin Colored contact lenses - recalled due to being distributed without FDA clearance Comp... photo #1
312   Comments Comment

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