The U.S. Food and Drug Administration has issued a recall of a Maquet Medical Systems USA medical device used during heart surgery. This came after reports that 51 injuries and at least one death have been caused by the device tearing tissue in the top left chamber of the heart. The FDA issued a Class 1 recall — the most serious of its kind — for Maquet’s TigerPaw System II in March after receiving word from the company that there were complaints about the device causing bloody tears in the heart. In issuing the safety alert, the FDA noted that 51 injuries and one death had been reported.
All 4,154 devices distributed between April 2013 and March 2015 were recalled, according to the FDA notice. Maquet, the New Jersey-based subsidiary of German device manufacturer Holding BV & Co. KG, picked up the TigerPaw system in 2013 when it acquired TigerPaw developer LAAx Inc., according to a company statement at the time announcing the merger. The system is used to obstruct the left atrial appendage during open heart surgery. Recently Maquet has been receiving complaints that the device is actually tearing the appendage and causing it to bleed, leading the company to send a letter to customers in March urging them to stop using the product. The TigerPaw System II was distributed only to hospitals.
The FDA said it has documented numerous violations at Maquet facilities in the past, with 45 recalls of its manufactured devices between 2009 and 2014, including five Class 1 recalls. In February, the FDA and Maquet’s parent company entered into a $6 million settlement to end a New Hampshire federal suit accusing the company of maintaining poor quality control at three subsidiaries. As part of that settlement, Maquet agreed to temporarily pull some products from its New Hampshire unit, including one that the FDA said might have led to a serious injury or death. According to a company statement, the TigerPaw recall is unrelated to the settlement agreement.
The FDA inspected the facility in Hudson, N.H., operated by subsidiary Atrium Medical Corp., along with facilities operated by two other subsidiaries in October 2013 and found major violations of quality system regulations, medical device reporting regulations and correction and removal regulations. While the New Jersey and German facilities will remain operational, Maquet will have to appoint an independent auditor to inspect the facilities and regularly report to the FDA on its compliance progress.
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