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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.
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 a 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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Do I Have a Catheter Recall Lawsuit?
The Medical Device Litigation Group at our 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 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.
