Penumbra (NYSE:PEN) has issued an urgent voluntary recall of all configurations of its Jet 7 Reperfusion Catheters with Xtra Flex Technology because the catheter may become susceptible to distal tip damage during use.
So far, Alameda, Calif.-based Penumbra has received 14 reports of death related to the problem out of the more than 30,000 distributed units. The device poses the risk of unexpected death or serious injury while used for removing clots in stroke patients. Distal tip damage with pressurization or contrast injection could result in potential vessel damage and patient injury or death.
The FDA has received over 200 medical device reports associated with the catheter, which includes deaths, serious injuries and malfunctions, according to the FDA warning letter.