Federal regulators have received more than 200 reports of malfunctions, serious injuries, and deaths associated with Penumbra Inc.’s JET 7 Reperfusion Catheters with Xtra Flex Technology (JET 7 Xtra Flex). Filing a Penumbra JET 7 Catheter Lawsuit could allow victims of these recalled medical devices to obtain compensation for their medical bills, pain and suffering, and other injury-related damages.
Our experienced medical device lawyers are offering free legal consultations to anyone who suffered serious injuries and complications that may have been caused by Penumbra JET 7 Reperfusion Catheters recalled in December 2020, including:
You may be eligible to file a Penumbra JET 7 Catheter Lawsuit if you or someone you loved suffered any of the above injuries during a blood clot removal procedure that followed an ischemic stroke. To contact the nationwide law firm of Bernstein Liebhard LLP, please fill out the form on this page or call our office direct at 1-888-994-5118.
In December 2020, the U.S. Food & Drug Administration (FDA) announced a Class I Medical Device Recall for Penumbra Jet 7 Catheters that utilize the Xtra Flex Technology, including:
Doctors use these devices during thrombectomy procedures to remove blood clots from their patients’ veins and arteries after an ischemic stroke, also known as a hemorrhagic stroke. These types of strokes occur when weakened blood vessels burst, causing blood to bleed into the brain.
The FDA granted 510(K) clearance to the JET 7 Catheter with Xtra Flex Technology on June 16, 2019, while the JET 7MAX Configuration was approved through the same process on February 27, 2020. The F510(k) program allows manufacturers to bring a new medical device to market without the benefit of clinical trials as long as they can show its design is “substantially equivalent” to another product that has already been approved through the FDA’s stricter pre-market approval program.
Unfortunately, reports of problems with the JET 7 Xtra Flex Catheters began to mount shortly after the devices came to market. In a July 2020 Notification to Healthcare Providers, Penumbra warned that the “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.” In August 2020, the FDA approved a new label warning against using contrast injection through the device.
But problems continued, and the Class I Recall – the FDA’s most urgent recall category — was announced less than 6 months later, on December 15, 2020. According to the recall notice, the devices suffer from a defect that could cause the catheters to separate near the distal tip during use and lead to life-threatening complications.
By that time, the FDA had received over 200 Medical Device Reports associated with the devices, including 20 reports detailing 14 unique patient deaths. Other adverse events linked to Jet 7 Xtra Flex Catheters include vessel damage, hemorrhage, and cerebral infarction. Device failure modes included ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region.
More than 30,000 units are affected by the recall, which did not include the Penumbra JET 7 Reperfusion Catheter with Standard Tip. In an Urgent Letter to Healthcare Providers, the FDA advised doctors and hospitals:
You may be entitled to compensation if you or a loved one suffered serious injuries or complications while undergoing a procedure that involved the use of a Penumbra Jet 7 Xtra Flex Catheter prior to January 1, 2021.
To discuss your case with a qualified Penumbra Jet 7 Catheter Lawyer at Bernstein Liebhard LLP, please fill out the form on this page or call the firm directly 1-888-994-5118.
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