Laax Recalls
2 recalls on record · April 29, 2015 to April 29, 2015 · Medical Devices
April 29, 2015Medical DevicesFDA
Laax, Inc. recalls TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener
Hazard: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
April 29, 2015Medical DevicesFDA
Laax, Inc. recalls TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener
Hazard: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.