Penumbra voluntarily recalled its popular catheter, JET 7 Xtra Flex, after surgeons reported serious and potentially fatal issues with the product. Reports from December 15th, 2020 say that while removing blood clots from the brains of patients, the distal tip of the Penumbra JET 7 Xtra Flex catheter would abruptly swell or break inside the artery of the brain. The expansion, sometimes several times the actual size of the artery, has allegedly led to ruptured blood vessels, massive brain hemorrhaging, and in some cases, death.
The U.S. Food and Drug Administration (FDA) issued an Urgent Letter to Health Care Providers that same day, instructing them to stop using the devices and suggesting facilities remove the products from their inventory, as advised in Penumbra’s Urgent Voluntary Medical Device Recall Notification. The FDA has acknowledged the receipt of more than 200 medical device reports (MDRs) related to the faulty catheter, some reporting patient deaths and others serious injuries like blood vessel damage, hemorrhage of the brain, and stroke.
According to the FDA the JET 7 Xtra Flex catheter was one of “the medical devices intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.”
Before the current recall, the FDA had already observed problems with the JET 7 Xtra Flex Catheter. The agency prompted Penumbra to issue a Notification to Healthcare Providers in July 2020 with immediate labeling requirements including additional warnings, precautions, and instructions to mitigate the risks associated with the use of the device. The following month, the FDA approved a new warning label advising against using contra injection through the device. According to Penumbra, more than 30,000 units of the device are affected by the recall and thus far, the company is aware of 17 injuries and 14 deaths resulting from distal tip damage and subsequent expansion and rupture.
What Can Injured Patients Do?
While we are not currently taking Penumbra cases other attorneys might be currently accepting injury cases from stroke patients who sustained an injury or from individuals who lost someone they love after they underwent a procedure that utilized the recalled device. In the meantime, you can find additional information about the faulty catheter here.