FDA issues class 1 recall for medical catheters

Editor's Note

The US Food and Drug Administration (FDA) has designated Route 92 Medical’s recall of products containing the Tenzing 7 delivery catheters as class 1, the most serious classification indicating risk of serious injury or death. The devices are used to deliver microcatheters to the blood vessels in the brain (neurovasculature) or used as an aspiration catheter to remove blood clots in patients with ischemic stroke.

According to a May 10 report, the company recalled specific lots of products containing the catheters, which were manufactured by an outside contract supplier, due to multiple instances of distal tip separation at the proximal marker band. The broken tips could delay surgery, block or otherwise harm blood vessels, and/or be left in the body. Two injuries and one death have been reported so far.