In December 2020, the U.S. Food & Drug Administration (FDA) announced a Class I recall for Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology (JET 7 Xtra Flex) because of a defect that could cause the devices to separate during use and lead to life-threatening adverse events.
The nationwide law firm of Bernstein Liebhard LLP is investigating the Penumbra JET 7 Catheter recall. If you or someone you love suffered an injury, including a second stroke or brain bleed, or died while undergoing surgery to remove blood clots after suffering an ischemic stroke, please call 1-888-994-5118 to arrange for your free, no-obligation Penumbra Jet 7 catheter lawsuit review.
This medical device recall involves all configurations of Penumbra Inc.’s:
Both products are “intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke.” An ischemic, or hemorrhagic, stroke occurs when weakened blood vessels burst, causing blood to bleed into the brain, damaging brain cells. People who have suffered a hemorrhagic stroke may find that the damaged areas are unable to function normally.
Penumbra’s reperfusion catheters are used by surgeons performing thrombectomy procedures to remove blood clots from the veins and arteries of their patients. During an imaging-guided procedure, a surgeon inserts the Penumbra catheter into the artery at the groin or wrist. The device is then guided up the body to the blocked artery in the brain. Once the clot is secured, the catheter system uses suction to remove the clot and restore blood flow.
Penumbra received 510(K) clearance to market the JET 7 Catheter with Xtra Flex Technology on June 16, 2019, while the JET 7MAX configuration received a similar clearance on February 27, 2020. The FDA’s 510(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 agency’s stricter pre-market approval program.
In July 2020, the Penumbra notified healthcare providers that it had received reports of distal tip expansion or rupture with these devices and updated the product’s labeling at that time. The Class I recall was announced less than 6 months later, on December 15, 2020.
By that point, the FDA had received over 200 medical device reports associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of the reports describe 14 unique patient deaths, which includes reports from different sources for a single adverse event.
Other reports described serious patient injuries, including 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 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,” the FDA said in its Urgent Letter to Healthcare Providers.
A Class I recall is the FDA’s most serious recall category and indicates that the use of a product poses a risk of significant injury or death.
Our medical device attorneys believe victims of the recalled Penumbra Jet 7 Catheters may be entitled to compensation for:
To learn if you qualify to file a Penumbra Jet 7 Catheter Lawsuit, please fill out our online form or call our office direct at 1-888-994-5118 to arrange for your free, no-obligation legal evaluation.
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