The recall, which affects some 4,154 of the TigerPaw II left atrial appendage closure devices, follows an increase in reports of torn tissue on the left atrial wall and bleeding during use of the device, the FDA said.
Maquet acquired the device when it bought LAAx Inc. for an undisclosed amount in May 2013. The TigerPaw II device is designed to occlude the heart’s left atrial appendage to treat post-operative stroke after open heart surgery for atrial fibrillation.
The problem that led to the recall "may or may not be caused by incomplete closure of the TigerPaw System II fastener," the safety watchdog said.
All TigerPaw II devices should be quarantined and returned to the company, the FDA said.
The devices were 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., according to the recall notice.