The U.S. Food & Drug Administration slapped three medical device companies with Class 1 recall status for their heart devices.
Boston Scientific Corp. (NYSE:BSX) got its second Class 1 status this week for a recall of 500 of its Innova stents from customers overseas.
Boston Scientific sent a letter to Innova customers outside of the U.S. May 13, according to the FDA, warning that it had received reports that the stent, used to treat lesions in the femoral artery and the adjacent proximal popliteal artery, failed to deploy completely or only partially deployed.
The Natick, Mass.-based medical device maker pulled 30,000 of its iCross coronary catheters last month, a recall which expanded to include the company’s Atlantis SR Pro2 model earlier this week.
The FDA also gave Class 1 status to a Datascope Corp. and Maquet Cardiovascular LLC intra-aortic balloon pump recall this week after the companies announced a voluntary field correction for their S98/98XT, CS100/CS100i and CS300 balloon pumps.
This looks like a bad year for Maquet, which underwent Class 1 FDA recall for some of its Heartstring II proximal seal systems in April.
Last but not least, Terumo Corp.’s (TYO:4543) coronary ostia cannulas got Class 1 status over concerns that foreign fragments of adhesive and plastic in the cannula tip could embolize and cause tissue damage, hemorrhaging or other serious injury, according to the filing.
