Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage

Date:  01/29/21

Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex

All Lots

Model or Catalog Numbers: The FDA’s Recall Classification Database

Manufacturing Dates:  May 10, 2019 – December 11, 2020

Distr Manufacturing Dates: ibution Dates: June 17, 2019 – December 14, 2020; 30,882 devices distributed

Devices Recalled in the U.S.:  22,656 devices.

Date Initiated by Firm: December 15, 2020

USA-FDA Link:  https://www.fda.gov/medical-devices/medical-device-recalls/penumbras-recall-jet-7-reperfusion-catheter-due-distal-tip-damage