Penumbra Issues Urgent Recall of JET 7 Catheters
The U.S. Food and Drug Administration (FDA) has alerted consumers and health care providers to an urgent recall of all Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology. This product is being recalled from the market because of an increased risk of death or serious injury when the product is used to remove clots from patients who had a stroke.
The FDA is urging people to immediately discontinue use of those products. Medical facilities should also take these catheters out of their inventory, as they are directed to do in the Urgent Voluntary Medical Device Recall Notification issued by Penumbra.
The recall applies to the following products:
- JET 7 Xtra Flex catheter
- JET 7MAX configuration, which includes the device above and the MAX Delivery Device
However, it is important to note the JET 7 Reperfusion Catheter with Standard Tip is excluded from this recall.
More than 200 medical device reports received by the FDA detail deaths, serious injuries and malfunctions. This includes 20 reports that detail 14 deaths. Some of the serious injuries that have been reported include:
- Cerebral infarction
- Blood vessel damage
There are also reports of device failure, including:
- Complete separation
- Exposure of internal support coils
The manufacturer conducted bench tests involving the catheter tip being plugged and pressurized until it fails. These tests revealed the JET 7 Xtra Flex catheter was unable to withstand the same burst pressures as other large bore aspiration catheters that can be used to remove clots in stroke patients.
The FDA is recommending all instructions from Penumbra’s Recall Notification be followed. This includes removing and quarantining unused products and returning affected products to Penumbra.
The FDA will continue to inform the public about new or additional information relevant to these dangerous products and the recall.
Notification to Health Care Providers Last Summer
On July 27, 2020, the FDA required Penumbra to issue a Notification to Healthcare Providers about more warnings, precautions and instructions to reduce the risk of using the JET 7 catheters that have now been recalled. Since then, reports about device failure have continued to be sent to the FDA. This led the FDA to ask Penumbra to voluntarily remove the device from the market.
Injured by a Defective Product? Call Phillips Law Group
Our Phoenix product liability lawyers offer a free legal consultation to discuss potential legal options after a defective product injury. There are no obligations and no upfront fees for our services.
If you have any questions, give us a call to schedule your free consultation. For more than 28 years, our attorneys have been helping injury victims throughout Arizona.
Phillips Law Group. Millions Recovered. Call 1-800-706-3000 .
Jon Jamieson was amazing to work with . He came through with all of his promises.
My paralegal , Caroline , was on top of her game - very responsive and always answered any questions I had and in a timely manner . My attorney Rob ,was the best attorney I ever had . He explained everything in great detail and had a great sense or humor . He really knows how to bring light To tough , unfortunate situations - I would absolutely recommend them at anyone -
I would like to thank Vanessa Rodriguez for helping me with my case because I was in total shock about the accident. She had listened to all my concerns and had answered every question I had . She was great !!!
Phillips is the best!! Love all that they do to give back to the community and how much they help those who are experiencing homelessness. ❤️
Great experience! Took care of pretty much everything, and I always felt like I want in good hands. Caroline Fa. was also a great help with everything. She always returned my calls and I never felt unheard. Even after my case she would still help me with my insurance documents.
Positive: Professionalism, Quality, Responsiveness, Value As someone who is familiar with the inner workings of the auto insurance industry I can whole heartedly endorse Steven J. Jones and Phillips law group as someone I would want on my side should litigation take place. They handled my case professionally, honestly, and with satisfactory results which I would not have expected without enlisting their help.
I want to thank attorneys Tim and Robert and the paralegal Bethany for all they had done on my case. They were all empathetic, knowledgeable and professional. All my questions were answered, emails returned in a timely matter, and promises fulfilled. I recommend Phillips Law Group if you need help with your injury case.
I would have no hesitation at all recommending Phillips Law Group. In particular, Juan Roque has impressed me with his professionalism, his integrity and his heart for the community!
Juan Roque has been integral with my legal needs. Communication has been easy. He conveys information I can easily understand without a lot of "Legal Fluff" jargon. I will certainly do business with Phillips Legal team again and refer them to my friends and family.
Definitely recommend! Awesome