Penumbra JET 7 Xtra Flex Catheter Lawsuits
In December 2020, Penumbra issued a recall for its JET 7 Xtra Flex Catheter because of device malfunctions resulting in serious injury or death. Stroke patients injured by the Penumbra JET 7 Xtra Flex Catheter while having a blood clot removed may be eligible to file a lawsuit against Penumbra.
Editors carefully fact-check all Drugwatch.com content for accuracy and quality.
Drugwatch.com has a stringent fact-checking process. It starts with our strict sourcing guidelines.
We only gather information from credible sources. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts.
Drugwatch.com has been empowering patients for more than a decade
Drugwatch.com has provided reliable, trusted information about medications, medical devices and general health since 2008. We’ve also connected thousands of people injured by drugs and medical devices with top-ranked national law firms to take action against negligent corporations.
Our team includes experienced medical writers, award-winning journalists, researchers and certified medical and legal experts. Drugwatch.com is HONCode (Health On the Net Foundation) certified. This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews.
The information on Drugwatch.com has been medically and legally reviewed by more than 30 expert contributors, including doctors, pharmacists, lawyers, patient advocates and other health care professionals. Our writers are members of professional associations, including American Medical Writers Association, American Bar Association, The Alliance of Professional Health Advocates and International Society for Medical Publication Professionals.
About Drugwatch.com
- Assisting patients and their families since 2008.
- Helped more than 12,000 people find legal help.
- A+ rating from the Better Business Bureau.
- 5-star reviewed medical and legal information site.
Testimonials
"Drugwatch opened my eyes to the realities of big pharmacy. Having a family member with major depression and anxiety, I was looking for information on her medications. I found information that was very helpful, that her psychiatrist never told her."
Penumbra’s urgent voluntary recall applies to all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex).
Doctors use these devices to remove blood clots and restore blood flow in people who have suffered an acute ischemic stroke. The catheter enters the body through a blood vessel in the leg and travels up through the neck. Once the catheter makes contact with the blood clot causing the stroke, doctors are able to vacuum out the clot and restore blood flow.
These reports included mentions of device malfunctions, causing serious injuries, including 14 patient deaths caused by distal tip damage and expansion and rupture following contrast injection.
Lawyers are currently filing lawsuits on behalf of injured stroke patients and family members who lost loved ones after procedures with JET 7 Xtra Flex Catheter.
These lawsuits were in the initial stages, and there have been no trials or settlements. But as of November 2022, there have been no significant updates and some lawyers have stopped taking these cases.
Reasons for the Recall
Penumbra issued its urgent voluntary recall because of device malfunctions and breakage that could cause injuries and death.
“Penumbra is recalling the JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death,” according to Penumbra’s Urgent Voluntary Medical Device Recall Notification.
Device failure reports 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” according to the U.S. Food and Drug Administration.
The FDA has provided 510(k) premarket notification numbers for the recalled devices.
FDA Actions and Label Warnings
After the clearance of the JET 7 Xtra Flex, the FDA received reports of device failure. The agency prompted Penumbra to issue a notification to health care providers with warnings and precautions to mitigate risks, according to the FDA’s recall notification.
On July 27, 2020, Penumbra sent a letter to health care providers with warnings.
“JET 7 Xtra Flex may become susceptible to expansion or rupture during contrast injection due to distal tip weakening from manipulation against resistance or use with other manufacturers’ revascularization devices. Distal tip expansion or rupture may cause vessel damage and subsequent patient injury or death,” the letter said.
The letter warned providers not to inject contrast media through the JET 7 Xtra Flex. Instead, they should use the guide catheter to inject contrast.
The labeling update did not stop reports of problems with the device. Some reports were related to providers not following instructions. The FDA requested that Penumbra remove all JET 7 Extra Flex from the market to protect patients.
Injuries People Are Suing For
Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology are associated with several potential side effects and complications. These include allergic reactions from contrast media, device malfunction, death, air embolism, hemorrhage at access site and infection.
Injuries in lawsuits are linked to device malfunction and breakage.
- Death
- Hemorrhage
- Stroke (cerebral infarction)
- Blood vessel damage
What to Do If You’ve Been Injured
If you choose to file a potential claim against Penumbra, contact an attorney right away. There are time limits to file an injury claim. Once this time limit passes, you won’t be able to seek potential compensation for injuries or death associated with the JET 7 Xtra Flex Catheter.
Gather all medical records and prepare to discuss details with your lawyer to see if you qualify to file a lawsuit.
The FDA recommends reporting the injury to MedWatch, the FDA Safety Information and Adverse Event Reporting program. This allows the FDA to identify risks with medical devices.
Make sure you discuss the injuries with your medical provider and understand what your options are for treatment.
Calling this number connects you with a Drugwatch.com representative. We will direct you to one of our trusted legal partners for a free case review.
Drugwatch.com's trusted legal partners support the organization's mission to keep people safe from dangerous drugs and medical devices. For more information, visit our partners page.