Published by Complimentary Private Legal Review: Should you or a family member have suffered harm due to a catheter, it’s imperative to get in touch with our legal team without delay. You could be eligible for financial restitution through a lawsuit, and our attorneys are here to assist.
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Penumbra Catheter Recall
Penumbra Inc. is recalling the following catheters over a risk of unexpected death or serious injury while used for removing clots in stroke patients:
- Penumbra JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- Penumbra JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.
The recall was initiated after the FDA “… received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunction,” the agency said in the recall letter. “Device failure modes reported in the MDRs include 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.”
This recall began on December 15, 2020.
What Can Go Wrong with the Penumbra JET 7 Xtra Flex Catheter?
In the medical reports sent to the FDA over Penumbra JET 7 Xtra Flex complications, physicians stated that the tip of the catheter (the distal tip) would suddenly expand or break while still inserted in the patient’s artery.
The sudden expansion of a balloon catheter can rupture an artery, causing bleeding in the brain that can result in the death of the patient.
If the tip breaks off, it could remain in the artery indefinitely, which may result in severe injuries and often requires additional revision surgery to remove the tip. In turn, these procedures can create additional risks to the patient’s health.
Of the 200 Medical Device Reports the FDA received associated with the Penumbra JET 7 Xtra Flex, at least 20 described 14 unique patient deaths. (There were different reporting sources for some of the single events.) Other reports described severe patient injuries including blood vessel damage, hemorrhage, and cerebral infarction (stroke).
Penumbra advised customers to remove all of its catheters from their inventory and return them to the company immediately.
Also Read: HawkOne Directional Atherectomy System Lawsuit
Venture Catheter Recall
Teleflex subsidiary Vascular Solutions has issued a Class I Recall for its Venture Catheters over a problem with excess material on the devices. Class I recalls are reserved for allegedly defective products that can cause serious adverse events or death.
The recall includes 3 lots of Venture Catheters [1], including 4,679 distributed in the U.S., due to the potential for excess material to be present within the inner lumen of the distal catheter tip.
The material could separate from the catheter and cause serious injury due to embolism, according to the U.S. Food & Drug Administration (FDA).
The recall covers all unexpired lots of the Rapid Exchange, Over-the-Wire, and Coronary Sinus versions of Venture Catheters. Affected product codes include 5820, 5821, and 5822, with an associated 72 different lot numbers.
Vascular Solutions said it has contacted purchasers with affected products, and advised any facilities with the products to remove them from their inventory and return them.
To date, no injuries or deaths have been associated with the catheter recall. This recall began in June 2017.
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FAQs
What types of injuries can result from defective catheters?
Injuries can include infections, internal bleeding, organ damage, blood clots, and other severe complications requiring medical intervention.
How can I find out if my catheter has been recalled?
You can check for recalls on the FDA website or consult your healthcare provider for information on whether your catheter is affected by a recall.
What should I do if I have a recalled catheter?
Contact your healthcare provider immediately for guidance. They may advise you to stop using the catheter and seek alternative treatment options.
Can I file a lawsuit if I was injured by a recalled catheter?
Yes, if you were injured by a recalled catheter, you may be eligible to file a lawsuit for compensation. Consult with a personal injury attorney specializing in medical device cases.
See all related medical device lawsuits our attorneys covered so far.
Do I Have a Catheter Recall Lawsuit?
The Medical Device Litigation Group at Schmidt Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in catheter recall lawsuits. We are handling individual litigation nationwide and are currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you were harmed by a catheter, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: