The U.S. Food and Drug Administration (FDA) has issued a class 1 recall of the TigerPaw System II, a left atrial appendage (LAA) closure device, due to reports that the device could cause the left atrial wall to tear and bleed. According to the FDA, this “may or may not be caused by incomplete closure of the TigerPaw System II fastener.” The device, described by the FDA as “an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage,” was approved by the Agency in 2010. All devices should be removed from stock and returned to Maquet, the manufacturer.

Keywords: Atrial Appendage, Heart Atria, Hemorrhage, Medical Device Recalls, Prostheses and Implants, United States Food and Drug Administration

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