What’s the Problem?
This FDA Recall began on Dec. 15, 2020, and affects:
- Penumbra JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- Penumbra JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.
“The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions,” the agency said. “Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event.”
The Penumbra JET 7 Xtra Flex catheter and JET 7MAX are used to restore blood flow by removing clots in patients suffering from acute ischemic stroke.
Tests have determined that the JET 7 Xtra Flex catheter cannot tolerate the same burst pressures as Penumbra’s other large bore aspiration catheters.
“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,” FDA said.
If you received a Penumbra Catheter that is affected by this recall, you should stop using it immediately. Facilities should remove the devices from inventory as directed, FDA said.
Do I Have a Penumbra Catheter Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Penumbra Catheter Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.