FDA Class I Recall for TigerPaw II Heart Device

FDA Class I Recall for TigerPaw II Heart Device

FDA Class I Recall for TigerPaw II Heart Device


On May 7, 2015, the U.S. 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 meant for use during heart surgery. The device is a surgical staple used to close tissue in the LAA. The TigerPaw system 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 recall was designated as a Class I recall, the FDA’s most serious designation, reserved for situations in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. As of March 30, 2015, Maquet Medical Systems had received 51 reports of adverse events and one death associated with the TigerPaw system.

The LAA is a small, ear-shaped sac located in the muscle wall of the left atrium, the top, left chamber of the heart. Its exact function is not known, the Cleveland Clinic explains, but in normal hearts, it contracts in collaboration with every heartbeat, pressing blood in the left atrium and LAA into the left ventricle, the bottom, left heart chamber. In patients diagnosed with atrial fibrillation—an irregular and often rapid heart rate—the electrical impulses controlling heartbeats do not move appropriately through the heart. Electrical impulses begin simultaneously spreading 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. When clots are pumped out of the heart, the individual may have a stroke. Individuals with atrial fibrillation are 5 to 7 times likelier to suffer a stroke than the general population. Individuals at risk for developing clots in the LAA may be candidates for a procedure in which the LAA is sealed to eliminate the risk of stroke and also eliminates the need for blood thinning drugs.

Maquet Medical Systems, on behalf of Laax, Inc., issued an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter on March 30, 2015, to all affected customers, advising that any inventory of the devices should be immediately examined for recalled TigerPaw System II devices. Recalled devices should be removed from inventory and returned to the company. The recall includes all serial numbers and lots of the device 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.

 

 

 

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