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Penumbra Recalled Catheter

Related Lawyers: James Gotz, Richard S. Lewis, Steve Rotman
Related Practice Areas: Mass Torts and Public Health Threats

People of all ages and states of health can suffer from development of a clot in an artery of their brain which, if left untreated, could block oxygen or blood flow and lead to a stroke, which can lead to death or disability.

Fortunately, there is a procedure called a thrombectomy which is available and oftentimes successful in removing these kind of clots in the brain, which in some cases can return the patient to their baseline state of health before they developed the clot. The procedure involves the use of a catheter (a thin tube) which is inserted through an available artery and moved into position to then suction or “aspirate” the clot, essentially acting like a micro-vacuum.

As of 2020, there are several aspiration catheters on the US market in a highly competitive industry where manufacturers vie with each other for hospital catheter lab medical professionals to purchase and use their product, and with competing claims by these companies of utilizing the latest and greatest medical technology. Alameda, California-based Penumbra, Inc. has been the industry leader in the development of the aspiration catheter and continues to hold the largest market share. In July, 2019, Penumbra brought to market the latest generation of its device, the JET 7 Xtra Flex. But, was Penumbra’s Jet 7 catheter rushed to market for business reasons while the company cut safety corners? And did the FDA fail to notice?

Since 2019, reports compiled by FDA’s monitoring system have shown that the tip of the JET 7 Xtra Flex catheter can expand and/or break during the thrombectomy procedure, which can in turn rupture a vessel or artery in the brain and result in catastrophic injuries such as brain bleeds, hemorrhagic strokes, and even death.

There are no similar reports of malfunction or deaths associated with any of Penumbra’s earlier-generation devices or those of its competitors. The issue appears to be unique to the JET 7 Xtra Flex. Penumbra’s current catheter was permitted on the market by FDA through a process by which the company did not have to demonstrate the safety of its device, only that it was equivalent to other products on the market.  But FDA does not independently test to verify these claims. However, in June 2020, Penumbra’s Japanese distributor warned hospitals about the new JET 7 Xtra Flex, noting that 11 deaths had already been reported in connection with use of the Jet 7 malfunctioning in only 11 months. The Japanese market letter mentions the “catheter expanding like a balloon, damaging the patient’s blood vessel.” Sale of the Penumbra JET 7 Xtra Flex in Japan was then suspended.

On December 15, 2020, Penumbra issued an “urgent” recall of the JET 7 Xtra Flex, which was “based on the risk of unexpected death or serious injury while used for removing clots in stroke patients.” Penumbra has directed all medical professionals to stop using this device. The FDA’s public notification of Penumbra’s recall states:

The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. Other MDRs describe serious patient injury such as vessel damage, hemorrhage, and cerebral infarction. Device failure modes reported in the MDRs 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.

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.

Through its industry-leading approach to monitoring for potentially dangerous drugs and medical devices, Hausfeld is one of the first firms in the country to identify and bring awareness to Penumbra’s unreasonably dangerous JET 7 Xtra Flex. With a reputation for always being on the tip of the spear when it comes to understanding and prosecuting the causation and science aspects in mass tort cases, Hausfeld lawyers have and continue to assess this case with some of the most regarded experts in the field. 

Our product liability group is now actively developing a team of leading lawyers around the country to identify patient victims and prepare cases for litigation to seek justice and fair compensation to address the impact on these patients and their loved ones.

If you or someone you know underwent a thrombectomy procedure to remove a clot in the brain, which resulted in a brain bleed causing death or related stroke disability, Hausfeld is ready to investigate the potential claim and if appropriate, prosecute it to the best possible outcome. Please contact our paralegal Ramon Rodriguez at rrodriguez@hausfeld.com.

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