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# Class 1 Recall of Penumbra Jet 7 Xtra Flex catheter
- URL: https://www.fdaweb.com/class-1-recall-of-penumbra-jet-7-xtra-flex-catheter/
- Published: 2021-01-29T12:00:00.000Z
- Updated: 2026-09-14T16:44:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148558

FDA has classified as Class 1 a Penumbra recall of its Jet 7 Xtra Flex catheter due to its potentially becoming susceptible to distal tip damage during use. 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 are intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within eight hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy, according to [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/penumbras-recall-jet-7-reperfusion-catheter-due-distal-tip-damage?ref=fdaweb.com). The recall does not apply to the Penumbra JET 7 Reperfusion Catheter with a standard tip.

FDA has received over 200 medical device reports (MDRs) associated with the catheter, including 14 deaths, the notice says. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction. “Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the Jet 7 Xtra Flex catheter,” it says.