Over 4 Million Catheters Recalled Due To Reports Of Fracture And Migration

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Catheters are inserted into the body through a small puncture made in the skin and into a blood vessel. The devices are then used for various reasons, including administering medications, injecting contrast dye for angiogram procedures, or removing small blood clots (thrombectomy) from veins and arteries.

Manufacturers have issued multiple urgent safety recalls for millions of these devices due to reports that the devices are breaking and migrating. Such failures can lead to perforation of blood vessels or embolization of fragments throughout the vascular system, including the lungs and heart, and they may cause death or serious injury. The FDA has classified these recalls as Class 1 recalls, which means the FDA has determined that using these products creates a reasonable probability of death or serious injury.

Brenes Law Group, P.C. and a consortium of other law firms have joined forces to take on these manufacturers. If you believe you or a loved one may have been injured by malfunctioning catheter, please contact us so that we can help you explore your legal options.

Cook Beacon Tip Technology Catheters

Since 2015, Cook has issued urgent recalls regarding all of its catheters employing Beacon Tip technology. Beacon tip angiographic catheters are used to introduce contrast dye into blood vessels in the heart to prepare for cardiac angiograms to prepare it for a cardiac angiogram used to diagnose heart conditions. Cook has admitted that these devices were suffering an unexpected and increasing incidence of polymer degradation of the catheter tip resulting in tip fracture and/or separation. Cook has further admitted that these events can cause serious injury and death to the patient. Therefore, hospitals and doctors have been warned to quarantine and discontinue use of all of these products. Affected units include, but are not limited to:

  • Beacon Tip Torcon TB Advantage Cather

  • Beacon Tip Royal Flush Plus High-Flow Catheter

  • Slip-Cath Beacon Tip Catheter

  • Shuttle Select Slip-Catheter

  • Beacon Tip Centimeter Sizing Catheter

Fetch 2 Aspiration Catheter

The Fetch 2 Aspiration Catheter is used to remove small blood clots from peripheral veins and coronary arteries (thrombectomy) to restore blood flow to the heart. These devices are subject to a Class 1 recall because the catheter shafts are breaking at various points along the device during procedures. Such failures can lead blockage of blood supply to the heart or blood vessels and resulting patient injury or death.

Free Legal Consultation

Brenes Law Group, P.C., is offering free and confidential legal consultation for anyone who believes that they or a loved one may have been injured by a defective catheter. We can help you determine if you have a worthwhile claim and may be entitled to compensation. Contact our firm by calling 877-690-4899.