Class 1 Recall of All TigerPaw System 2 Medical Devices
Overview of the TigerPaw System 2
Diagnostic and Interventional Cardiology reports that the TigerPaw System 2 is made by LAAx and is intended to reduce the risk of stroke and atrial fibrillation by occluding the left atrial appendage.
Maquet Cardiovascular bought LAAx and the TigerPaw System 2 device in May 2013 shortly before the device came on the market in the United States, according to a press release announcing the purchase.
The British Medical Journal explains that the left atrial appendage is a small sack that sits off the left atrium and can act a pressure release during periods of high left atrial pressure.
The Cleveland Clinic explains that patients with atrial fibrillation do not empty the appendage completely; increasing the risk of stroke so closing the appendage is one option in reducing stroke risk.
TigerPaw System 2 Recalled Due to Reports of Tissue Tearing and Bleeding
Cardiovascular Business reports the FDA has recalled over 4,100 of the TigerPaw System 2 medical devices.
The class 1 recall of the TigerPaw System 2 was issued because of increasing reports to the FDA of tissue tearing and bleeding associated with the device, according to FierceMedicalDevices. The FDA issues a class 1 recall when the agency believes there is a reasonable possibility that using the medical device could lead to serious injury or death.
The company has notified hospitals and doctors that all serial numbers and all lots of the TigerPaw System 2 have been recalled and to remove any remaining devices from their inventory, according to the FDA announcement.
TigerPaw System 2 Recall Latest in String of Troubles for Maquet
In February 2015, the United States Department of Justice announced that an injunction had been obtained to prevent Maquet from continuing to violate FDA manufacturing regulations.
FierceMedicalDevices explains that Maquet had violated a number of FDA manufacturing regulations at its New Hampshire facility and the injunction closed down the facility. The FDA has also suspended five of the company’s products from the market according to PharmaNewsToday.
Outpatient Surgery Magazine reports there have been over 45 recalls of Maquet medical devices since 2009 and that 5 of these recalls have been deemed class 1 recalls, the most serious recall issued by the FDA.