51 reports of personal injuries and one death prompt the FDA to announce an urgent Class I Recall of Maquet’s Tiger Paw System II, a medical device used during heart surgery

A defective surgical staple used to close tissue in the left atrial appendage of the heart is being recalled by the FDA after reports that patients suffered personal injuries such as tissue tears and bleeding  including a possible tear of the left atrial wall (top left chamber) during use of the device.   The manufacturer of the defective medical device, Maquet Medical Systems, sent an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter to all affected customers asking them to immediately remove and quarantine the Tiger paw System II from their inventory.

Read the press release from the FDA