Tag: recall

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Getinge Subsidiary’s Intra-Aortic Balloon Pumps Get Class I Recall

Getinge subsidiary Datascope is recalling two types of Intra-Aortic Balloon Pumps due to the possibility of unexpected device shutdown.

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Gaps in Recalls of Home Medical Devices Top ECRI’s Hazards List

ECRI has named gaps with recalls of home-use medical devices as the nation's most pressing health technology safety issue for 2023.

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Medtronic Recalls Ventricular Assist Device Batteries

Medtronic is recalling HeartWare Ventricular Assist Device System batteries due to their ability to experience electrical faults that cause them to unexpectedly fail.

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Getinge Subsidiary’s Intra-Aortic Balloon Pumps Get Class I Recall

Getinge subsidiary Datascope is recalling two types of Intra-Aortic Balloon Pumps due to the possibility of unexpected device shutdown.

Unpacking Averages: Common Root Causes Driving Medical Device Recalls

Jul 14, 2022

The National Law Review published data aimed at providing insight for companies regarding product recalls.

Sleep Apnea Devices Show ‘Very Low’ Amount of Degraded Foam, Philips Says

Jun 30, 2022

A recall related to one of Philips sleep apnea devices may not have been as serious or widespread as previously believed.

GE Healthcare Recalls Certain Ventilator Batteries Due to Early Failure Issues

Jun 29, 2022

Backup batteries for GE Healthcare’s CARESCAPE R860 ventilator were recalled because they may run out before they are expected to do so.

Medtronic, Baxter Face FDA Class I Labels for Separate Recalls of Heart Pumps, Ventilators

Jun 27, 2022

Amid continued recall concerns, devices from Medtronic and Baxter were recently assigned the most serious recall type be the FDA.

BD Voluntarily Recalls Intraosseous Products

Jun 23, 2022

BD announced a voluntary recall on its Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers.

Dräger’s Breathing System Filter Recall Gets Class I Label from FDA After Ventilation Obstruction

Jun 14, 2022

Dräeger Medical, Inc. expanded on its voluntary recall of Lot LT2103 of Draeger SafeStar 55 Breathing System Filters.

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Medtronic’s HVAD Pump Implant Kit Gets Class I Recall for Weld Defect

Medtronic recalled its HeartWare Ventricular Assist Device System, which is designed to help the heart pump blood to the rest of the body.