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FDA Medwatch News Feed

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped | Mon, 01 Mar 2021 00:00:00 EST

The HeartWare HVAD system pump is used in patients with heart failure. Some pumps had delayed or failed restarts, which may cause serious risk to patients.

Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System | Tue, 23 Feb 2021 00:00:00 EST

Medtronic plc , the global leader in medical technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.

Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit | Fri, 19 Feb 2021 00:00:00 EST

EMBLEM S-ICD is an implantable defibrillator. In some devices, moisture may get inside and keep the device from shocking the heart to fix heart rhythm.

2021 Safety Communications | Fri, 19 Feb 2021 00:00:00 EST

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

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