As we previously mentioned, the FDA classified a recent recall of the TigerPaw System II medical device a class I recall. This recall was issued due to potential TigerPaw Bleeding Injury and TigerPaw Tearing Injury to patients. The recall affects 4,154 devices distributed in the United States and is related to the possibility of incomplete closure of the device.
The TigerPaw System II was approved by the FD in May 2011 for occlusion of the left artrial appendage. it is intended to be used in cases of left atrial appendage occlusion when the doctor can directly see the heart without the use of a camera or other devices. When implanted during heart surgery, the TigerPaw System II was indicated to seal the left atrial appendage (LAA), a small sac located in the top left chamber of the heart. The device’s intended purposes was to bind itself to this small sac so that blood could not collect in this area and form clots.
LAAx, Inc. began distributing the device in May 2013.
We would welcome the chance to discuss any questions you may have about your TigerPaw Bleeding Injury or other questions at (800) 632-1404.