The Food and Drug Administration (FDA) has announced a recall of all lots of Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex.

As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are medical devices intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.Penumbra recalled the Penumbra JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use.

The FDA has identified this recall as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions.

Food and Drug Administration (FDA). Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage [news release]. January 29, 2021. Available at: click here. Accessed February 1, 2021.