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Recalls and Safety Alerts:
Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication
Health professionals should be aware that the safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established. To reduce the risk of stroke in patients with atrial fibrillation, consider treatment options for which safety and effectiveness have been established. Prior to treatment, inform atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke...
Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall
The oxygen intake port may be blocked which can prevent the bag from filling. This may prevent the device from delivering breathing support to the patient. Teleflex sent an urgent medical device recall letter to customers asking them to immediately discontinue use and quarantine the recalled product...
FLOW-i Anesthesia Systems by Maquet: Class I Recall
The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of system. This may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately...
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