Penumbra JET 7 Xtra Flex Catheter

Our product liability group uses the civil justice system to hold manufacturers accountable when unreasonably dangerous drugs and medical devices cause real and serious harm to patients. The team is drawing the attention to a surgical device designed to help stroke victims, but which actually can kill or permanently disable them.  

Background

People of all ages and all 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, in turn potentially leading to death or disability.  Fortunately, a thrombectomy procedure can successfully remove such  clots in the brain, and in some cases the patient  can return to their baseline state of health pre clot development. The procedure involves the use of a catheter (a thin tube) which is inserted through an available artery and moved into position to then suck or aspirate" the clot, essentially acting like a micro-vacuum.

Currently, there are several aspiration catheters on the US market. This is a highly competitive industry where manufacturers vie with each other to convince hospital professionals to purchase and use their product, all claiming they utilize the latest and greatest medical technology. 

The JET 7 Xtra Flex

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.

Since 2019, FDA reports 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. Was Penumbra’s Jet 7 catheter rushed to market for business reasons while the company cut safety corners? Did the FDA fail to notice?

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 the 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.  The FDA does not independently test to verify these claims.  In June 2020, Penumbra’s Japanese distributor warned hospitals about the new JET 7 Xtra Flex, noting that 11 deaths had been reported in connection with 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.

Recall

On December 15, 2020, Penumbra issued an "urgent" recall of the JET 7 Xtra Flex, based on the risk of unexpected death or serious injury while used for removing clots in stroke patients." Penumbra directed all medical professionals to stop using this device.  The FDA’s issued a public notification of Penumbra’s recall stating it had received over 200 associated medical device reports (MDRs) including deaths, serious injuries, and malfunctions - such as vessel damage, hemorrhage, and cerebral infarction and describing a wide range of device failure modes.  

Action

Hausfeld is one of the first firms in the country to identify and bring awareness around Penumbra’s unreasonably dangerous JET 7 Xtra Flex catheter.  With a reputation for being on the tip of the spear when it comes to understanding and prosecuting the causation and science aspects in mass tort cases, we are assessing this case with some of the most regarded experts in the field. 

Our product liability team is actively developing a team of leading lawyers 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, we are ready to investigate the potential claim and if appropriate, prosecute it to the best possible outcome.   Please contact one of the related lawyers or complete the form below.

HAVE YOU BEEN AFFECTED?

If you believe that you or a loved one may have been harmed by this product, and would like to learn more, please contact Ramon Rodriguez at rrodriguez@hausfeld.com, or complete this form.

Please do not include any confidential information when contacting the related lawyers or submitting this form. No lawyer-client relationship is formed unless and until an engagement agreement is signed.

Data protection and privacy