Penumbra Recalls JET 7 Xtra Flex Catheters Following Reports of Serious Injuries, Patient Deaths
Written by Faith Anderson on December 29, 2020
Penumbra is recalling more than 30,000 units of its JET 7 Catheters with Xtra Flex Technology (JET 7 Xtra Flex) due to concerns about an increased risk of serious injury and death in ischemic stroke patients who undergo blood clot removal procedures in which the aspiration catheters are used. The catheter recall was announced after the FDA received more than 200 reports of device failures like expansion, rupture and breakage of the JET 7 Xtra Flex Catheters occurring during clot removal procedures, which can put patients at risk for hemorrhage, vessel damage, cerebral infarction (stroke) or even death. If you suffered a serious injury or lost a loved one as a result of problems associated with Penumbra’s recalled JET 7 Xtra Flex Catheters, you are not alone. Our consumer advocates at Consumer Justice Foundation can help put you in contact with a reputable product liability attorney who has experience representing consumers harmed by dangerous and defective medical products.
Urgent Voluntary Recall of JET 7 Xtra Flex Catheters
Penumbra’s JET 7 Xtra Flex Catheter is an aspiration catheter commonly used during thrombectomy procedures to remove blood clots in patients experiencing an ischemic stroke. An ischemic stroke occurs when a blood clot blocks an artery that supplies blood to the brain, which can lead to brain damage or the death of brain cells. The JET 7 Xtra Flex Catheter is designed to be inserted into a patient’s wrist or groin and guided to the blocked artery in the brain. The catheter then acts like a vacuum inside the artery to remove the clot and restore blood flow, and when it works properly, it can mitigate the risk of serious complications caused by a lack of blood and oxygen supplied to the brain. However, new information suggests that the catheter may be subject to distal tip damage during normal use in clot removal procedures, which can increase the risk of bleeding in the brain and subsequent patient death. The FDA announced the urgent voluntary recall of the JET 7 Xtra Flex Catheters on December 15, 2020, in a letter to healthcare providers.
The Penumbra catheter recall affects all configurations of the Penumbra JET 7 Xtra Flex Catheter, which are being removed from the market “based on the risk of unexpected death or serious injury while used for removing clots in stroke patients.” This includes the JET 7 Xtra Flex catheter, originally cleared by the FDA in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device), cleared by the FDA in February 2020. According to the FDA’s recall announcement, “Bench testing performed by the manufacturer, where the catheter distal tip is plugged and pressurized to failure, demonstrates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large bore aspiration catheters used to remove thrombus in acute ischemic stroke patients.”
Medical Device Reports Highlight Serious Patient Injuries and Deaths
Since initially clearing Penumbra’s JET 7 Xtra Flex Catheter and Jet 7MAX configuration, the FDA has continued to monitor the devices for performance and postmarket safety. In the short amount of time the catheters have been on the market in the United States, the FDA has received as many as 239 medical device reports associated with the recalled catheters. According to the agency, 20 of the medical device reports describe 14 unique patient deaths and others describe serious injuries to patients occurring during surgical procedures to remove blood clots from the brain, including potentially life-threatening arterial ruptures, brain bleeds and strokes. Device failures described in the adverse event reports include unexpected rupture, ballooning, expansion, breakage or complete separation of the device, as well as exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex Catheter.
History of Problems with Penumbra’s JET 7 Xtra Flex Catheters
This is not the first time concerns have been raised about the safety and efficacy of Penumbra’s JET 7 Catheters with Xtra Flex Technology. In July 2020, the FDA prompted Penumbra to issue a Notification to Healthcare Providers containing “immediate labeling mitigations that included additional warnings, precautions, and instructions to mitigate risks associated with use of the device by health care providers.” The notification warned that distal tip expansion or rupture can occur with JET 7 Xtra Flex Catheters used during injection of contrast media. According to Penumbra, “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.” The manufacturer warned that these device failures may cause vessel damage and subsequent injury or death to patients.
Unfortunately, even after the Notification to Healthcare Providers and the labeling update was issued, the FDA continued to receive new medical device reports describing the same types of device failures. It was because of this persistent risk to patients that the FDA ultimately requested that Penumbra remove the JET 7 Xtra Flex Catheters from the market. If you were successfully treated with a JET 7 Xtra Flex Catheter, Penumbra’s recall does not affect you. However, if you suffered a complication like vessel damage, hemorrhage or stroke during a clot removal procedure in which a recalled JET 7 Xtra Flex Catheter was used, you may qualify for financial compensation for your medical expenses and other damages, which you can pursue by filing a product liability lawsuit against Penumbra. You may have grounds to file a wrongful death lawsuit against the manufacturer if you lost a loved one due to complications resulting from a Penumbra JET 7 Xtra Flex Catheter device failure.