Class I Recall Announced for TigerPaw II Heart DeviceMay 8, 2015
This week, the Food and Drug Administration (FDA) announced the recall of the TigerPaw System II by Maquet Medical Systems.
The TigerPaw II is an implantable left atrial appendage (LAA) occlusion device intended for use during heart surgery. The TigerPaw is a surgical staple used to close tissue in the LAA. The device is being recalled because there are reports that it may not close completely, resulting in tears and bleeding in the heart tissue, including a potential tear on the left atrial wall during use of the device.
The FDA has designated this a Class I recall, the most serious category, which the agency reserves for situations in which there is a reasonable probability that the use of or exposure to the recalled product will cause serious adverse health consequences or death. Maquet Medical Systems had received 51 reports of adverse events and one death associated with the TigerPaw system as of March 30, 2015.
The left atrial appendage is a small, ear-shaped sac located in the muscle wall of the left atrium, which is the top, left chamber of the heart. Though its exact function is not known, the Cleveland Clinic explains that in normal hearts it contracts with every heartbeat, pressing blood in the left atrium and LAA into the left ventricle, the bottom, left heart chamber. In patients with atrial fibrillation-an irregular and often rapid heart rate-the electrical impulses controlling heartbeats do not move appropriately through the heart. Impulses may simultaneously spread through the atria and the disordered impulses do not allow the atria to appropriately and effectively contract or move blood into the ventricles. Blood may collect in the LAA and form clots. If the clots are pumped out of the heart, the individual may have a stroke, and people with atrial fibrillation are 5 to 7 times more likely to suffer a stroke. Patients at risk for developing clots in the LAA may be candidates for a surgical procedure to seal the LAA to eliminate the risk of stroke and also eliminate the need for blood thinning drugs often prescribed for those with atrial fibrillation.
Maquet Medical Systems issued an "Urgent Medical Device Recall (Removal) Immediate Action Required" letter to customers on March 30, 2015, advising them to removed any of the affected devices from inventory immediately and returned them to the company. The recalled devices include all serial numbers and lots with part number C-TP-1507 (7 connector). A total of 4,154 units of the affected device were distributed in the U.S. from April 1, 2013 through March 23, 2015.