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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

Image Credit: |

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL
Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL (Posted yesterday)

The U.S. District Judge presiding over all Suboxone lawsuits has created a mentorship program to use the litigation to provide some attorneys an opportunity to gain experience in handling complex federal multidistrict litigations.

Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M
Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M (Posted 3 days ago)

Gilead says it will pay $40 million to resolve HIV drug lawsuits over Truvada, Atripla, Viread, Stribild and Complera pending in the federal court system, involving claims that the the company sat on safer formulations of the drugs for years to increase profits.