On December 15, 2020, the U.S. Food and Drug Administration (FDA) announced Penumbra, Inc.’s recall of all Penumbra JET 7 Xtra Flex catheters due to the “risk of unexpected death or serious injury.” Penumbra, Inc.’s recall included a warning that all medical facilities who used the Penumbra JET 7 Xtra Flex catheter should remove them from their inventory.
How the Penumbra JET 7 Xtra Flex Catheter Is Supposed to Work
The Penumbra JET 7 Xtra Flex catheter is part of the Penumbra System which was designed to work in tandem with the Penumbra Aspiration Pump, Penumbra Aspiration Tubing, and the MAX delivery device to restore blood flow by removing blood clots. This intended to be achieved by using continuous aspiration (a method that uses suction to remove a blood clot) in patients who have suffered from an acute ischemic stroke within 8 hours of symptoms appearing. The Penumbra JET 7 catheter series was intended to deliver deeper vacuum aspiration power to allow the practitioner to safely extract blood clots in acute ischemic stroke patients.
During a catheter-based thrombectomy procedure, the surgeon makes an incision in the groin and advances a catheter through an artery all the way to the blood clot. The surgeon uses an X-ray to guide the catheter to the blood clot. The catheter then removes the blood clot from the blood vessel in order to restore blood flow.
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Penumbra JET 7 Xtra Flex Catheter Defects
The FDA has received more than 200 medical device reports associated with the Penumbra JET 7 Xtra Flex catheter. The reports include complications such as death, serious injuries, and malfunctions. The report listed device failure modes as “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.”
The distal tip is located at the very top of the catheter and is what makes contact with the blockage within the vessel. However, in the case of the Penumbra JET 7 Xtra Flex catheter, the distal tip may expand to become several times the diameter of the blood vessel. This expansion can put undue pressure on the weakened blood vessel and can lead to an increased risk of rupturing. If the blood vessel ruptures within the brain, the brain tissue can be flooded with excess blood which causes damage to the brain and may result in a serious brain bleed (a hemorrhagic stroke) or even death.
Penumbra, Inc. conducted testing that confirmed this potentially fatal complication. To come to this conclusion, the manufacturer compared the Penumbra JET 7 Xtra Flex catheter to its other aspiration catheters. It determined that the Penumbra JET 7 Xtra Flex catheter’s distal tip could not withstand as much pressure as the other aspiration catheters before failing–resulting in the distal tip expanding and potentially causing the blood vessel to rupture. This means that the Penumbra JET 7 Xtra Flex catheters have an increased risk of failure compared to other aspiration catheters. The FDA confirmed these concerning findings in its December 15, 2020 announcement of Penumbra, Inc.’s voluntary recall of the Penumbra JET 7 Xtra Flex catheter.
GoldenbergLaw Can Help
If you or a loved one have been harmed by a Penumbra JET 7 Xtra Flex catheter malfunctioning, contact the Hemorrhagic Stroke Attorneys at GoldenbergLaw who have more than thirty years of experience in fighting for justice. Contact us today for a free Penumbra Jet 7 lawsuit consultation and let us give you the Gold standard of advocacy you deserve!