Penumbra Catheter Recall Over JET 7 Xtra Flex Tip Damage Categorized as Class I by FDA

Federal regulators indicate a Penumbra Jet 7 catheter recall initially announced in December should be considered a Class I recall, meaning use of the catheter poses a risk of serious injury or death.

The FDA originally posted information about the Penumbra catheter recall in December, in a letter to healthcare providers which warned the Jet 7 Xtra Flex catheters should no longer be used due to a risk of distal tip damage. Facilities were directed to remove the recalled catheters from their inventories, and the agency indicates in a statement posted last week that the action is considered the most serious type of medical device recall.

Nearly 31,000 Penumbra Jet 7 Reperfusion Catheters with Xtra Flex Technology, also known as JET 7 Xtra Flex, are impacted by the recall. The products were distributed between June 17, 2019 and December 14, 2020.

The FDA reports receiving more than 200 medical device reports involving problems with Penumbra JET 7 Xtra Flex catheters involving serious injuries. Among the data are 20 medical device reports describing at least 14 unique patient deaths. Problems mentioned in the reports include vessel damage, hemorrhage, and cerebral infarction that may have resulted from a malfunction or failure.

The Jet 7 Xtra Flex catheter was one of Penumbra’s “flagship” products, which was designed to be inserted into an affected artery, navigated to a blood clot and used to suck the clot out of a patient’s body. However, by mid 2020, the lawsuit indicates Penumbra knew about problems with the catheter, after a distributor in Japan sent a warning to hospitals about catheter failures, and stopped selling the product in the country.

Approximately one month later, on July 27, 2020, Penumbra sent a warning to physicians and other healthcare providers about incidents where the distal tip broke or expanded, which put patients at risk of serious injury or death.

In the wake of the incident, Penumbra now faces a class action lawsuit filed earlier this month seeking to represent investors who lost money when the company’s stock value plummeted due to the recall. The lawsuit alleges Penumbra deceived investors about the success and safety of the catheters.