Penumbra Recalls Catheter Due to Distal-Tip Damage
California-based devicemaker Penumbra has recalled all lots of its JET 7 Reperfusion Catheter with Xtra Flex Technology that was manufactured from May 10, 2019, to Dec. 11, 2020, because of adverse events linked to the catheter’s distal-tip region.
The device is used to restore blood flow by removing clots in patients experiencing an acute ischemic stroke. The recall affects almost 31,000 catheters, including 22,656 in the U.S.
The FDA said it has received more than 200 reports associated with the catheter, including 14 deaths. The reported failures included ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the catheter’s distal tip region.