FDA deems all 4,000+ of troubled Maquet's left atrial appendage closure devices potentially deadly, announces major recall

A horrendous year for Germany's Maquet Holding just got worse. On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of its facilities, the suspension of 5 of its devices from the market and a $6 million fine, the FDA announced the recall of all 4,154 units of Maquet's stroke-fighting TigerPaw System II left atrial appendage closure device.

It's a Class I recall, reserved for cases in which the FDA believes there is a reasonable probability that the device "will cause serious adverse health consequences or death."

The recall notice says that there has been an "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."

The device is indicated for "for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures," according to its FDA clearance/510(k) notice from 2011. The first generation TigerPaw System was cleared in 2010.

In a more promiment release about the recall, the FDA later revealed that 51 reports of adverse events and one death related to the device. 

In 2012 Japan's Terumo became the TigerPaw II's exclusive distributor in the U.S.

The TigerPaw II is supposed to reduce the risk of post-operative stroke by reducing atrial fibrillation--an irregular and often rapid heartbeat that tends to precede the condition--by blocking the heart's left atrial appendage.

The FDA recall notice states that LAAx, acquired by Maquet in June 2013, sent a recall letter to customers on March 30. The customers were asked to remove and quarantine the faulty TigerPaws and send a form to the company. A Maquet sales representative is supposed to help the customers return the product.

The FDA says that the recall affects all serial numbers and lots of the device. It has been distributed throughout the U.S. and Europe, as well as some Middle Eastern countries.

"Patients must be assured that medical devices are safe, effective and high quality," said Jan Welch, acting director of the Office of Compliance in the FDA's device arm (CDRH), in a statement following the permanent injunction that suspended manufacturing of several devices at Maquet's Hudson, NH, manufacturing facility. "The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance."

The injunction occurred as a result of 10 inspections and 45 previous recalls of Maquet devices. Maquet is a subsidiary of Sweden's Getinge Group.

Boston Scientific ($BSX) recently received approval for its Watchman left atrial appendage closure device in March. But that device went through the stringent PMA approval process, and is the only device classified a classified as a system for left atrial appendage closure.

The TigerPaw was cleared using the less rigorous 510(k) pathway, and is one of several devices classified as an implantable staple.

In an emailed statement Maquet said, "This recall of the TigerPaw System II was initiated on a voluntary basis by Maquet Medical Systems in February. The products were distributed only to hospitals and the recall is virtually complete. The recall has been classified by FDA as a Class I recall. Maquet is conducting  this recall in accordance with all requirements for a Class I recall. Unfortunately, voluntary recalls are needed from time to time in the medical device area.  Maquet monitors the use of its medical devices closely and conducts voluntary recalls when needed, always notifying the FDA, as required. This voluntary recall is unrelated to the recent agreement by Maquet and FDA on a consent decree."  

- here's the recall notice
- here's a release about the recall 

Editor's Note: Additional information from FDA about deaths and adverse events was added.