On December 15, 2020, the U.S. Food and Drug Administration (FDA) announced that Penumbra, Inc. had recalled all Penumbra Reperfusion Catheters with Xtra Flex Technology (Jet 7 Xtra Flex). The recall is due to the heightened risk of injury and death during procedures to remove blood clots in stroke patients.
The Jet 7 Xtra Flex catheter has been used in thousands of procedures since it was introduced to the market in 2019. Many patients may soon be notified by their care provider that this recalled device was used in a recent procedure.
It can be an immensely scary and confusing experience to learn that a recalled and potentially dangerous device was used in your surgery. The Jet 7 Recall Lawyers at GoldenbergLaw are here to help you hold this company responsible. If you qualify, you may be entitled to substantial compensation. This is not a class action. If you qualify, you will have your own individual claim.
Why Did Penumbra Recall the Penumbra Jet 7 Xtra Flex Catheter?
Penumbra’s recall urged all medical providers to stop using the device and for all facilities to remove the devices from their inventories due to increased risk of serious injury and even death.
The recall came after the FDA received over 200 medical device reports associated with the Jet 7 Xtra Flex catheter. These reports included cases where patients died or suffered serious injuries after the device malfunctioned.
The device failures 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.”
If the distal tip expands within a cerebral artery, the tip can become multiple times the size of the artery which can result in it being damaged or rupturing. If the distal tip breaks off during the procedure, it can cause serious injuries requiring further interventions to recover and remove the separated part of the catheter.
What Injuries are Linked to the Penumbra Jet 7?
Reports demonstrated that when the Penumbra Jet 7 Xtra Flex catheter was used to remove blood clots from patients’ brains the distal tip would expand or fracture spontaneously. Surgeons observed that this resulted in the catheter expanding within a cerebral (brain) artery. This expansion caused the blood vessel to rupture which can cause the following complications:
- Vessel damage
- Hemorrhagic stroke
- Cerebral infarction
- Additional surgery
Do I Have a Penumbra Jet 7 Lawsuit?
If you or a loved one have suffered a serious injury during a medical procedure (thrombectomy) in which the Penumbra Jet 7 Xtra Flex Catheter was used, you may be eligible for a lawsuit against the manufacturer. The Penumbra Jet 7 Recall Attorneys at GoldenbergLaw have over thirty 34 of experience litigating cases against device manufacturers and helping our clients successfully receive the justice they deserve. We have the expertise, compassion, and knowledge to help you with your Penumbra Jet 7 lawsuit wherever you reside in the United States. Contact us today for a free consultation and leave the sleepless nights to us.