The FDA issued a Class I recall on more than 4,100 TigerPaw II implantable left atrial appendage occlusion devices based on reports of possible tissue tearing and bleeding.

The TigerPaw II has a soft silicone fastener that is designed to conform to the appendage anatomy and tissue thickness when placed on the ostium of the left atrial appendage during cardiac surgery. The FDA’s notice cited reports of injury to the left atrial wall, but it was not clear if incomplete closure of the fastener played a role in the problem.

The device is made by LAAx, which was acquired by Maquet Medical Systems in 2013. It became commercially available in the U.S. in May 2013 and in Europe in June 2013.

Maquet sent recall letters to customers on March 30 with instructions to remove TigerPaw II products and return them. The recall affects both model numbers. The devices have been distributed in the U.S., Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and the U.K.