What's the Problem?
According to the U.S. Food & Drug Administration (FDA), this recall 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.
This recall was issued after the FDA received at least 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions.
"Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event," FDA said. "Other MDRs describe serious patient injury such as vessel damage, hemorrhage, and cerebral infarction."
The Penumbra JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are used to restore blood flow by removing clots using continuous aspiration in patients suffering from acute ischemic stroke within 8 hours of symptom onset.
Testing by Penumbra has found that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as Penumbra's other large bore aspiration catheters used to remove clots in stroke patients.
"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.
This recall began on December 15, 2020.
Do I Have a Penumbra Catheter Lawsuit?
The Medical Device 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.