Penumbra Urgently Pulls JET 7 Catheters from Market Following 14 Reported Deaths
On December 15, 2020, Penumbra issued an urgent recall of its JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) following numerous reports of unexpected death or serious injury. Penumbra’s JET 7 Xtra Flex is a catheter used for removing blood clots and restoring blood flow in stroke patients. However, testing and adverse event reports suggest that the catheters may be prone to damage near the distal tip region during use. Damage in the distal tip region could cause ballooning, expansion, rupturing, separation, and exposure of coils in the JET 7 Xtra Flex catheter, which could be fatal.
Why Is the Penumbra Jet 7 Catheter Device Being Recalled?
According to the FDA’s urgent letter to health care providers, it has already received more than 200 reports of problems associated with the Penumbra device, including deaths, serious injuries, and malfunctions. Unfortunately, those reports describe the deaths of 14 patients. The reports also describe 17 serious patient injuries such as blood vessel damage, hemorrhage, and “cerebral infarction,” a medical term for brain tissue damage due to lack of oxygen. Accordingly, the FDA has labeled this a Class I recall, its most serious designation reserved for products that pose a reasonable probability of severe injuries or death. The recall affects more than 30,000 devices distributed following the device’s introduction to the market in 2019.
If you or a loved one has suffered injuries that you suspect were caused by an Penumbra JET 7 Xtra Flex catheter, contact one of the experienced medical device attorneys at Burg Simpson’s Cincinnati office today. Our compassionate team of lawyers possess the skills and resources to investigate your potential claim and fight for the justice and compensation you deserve. Call us at 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.