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Defective Catheters Causing Injury

Santa Clara, CA: Over 4,000,000 catheters have been recalled due to reports that the defective medical devices can fracture and migrate through a patient’s body, leading to perforation of blood vessels; embolization of fragments throughout the vascular system, including the lungs and heart; and may, cause death or serious injury.

Catheters are used for many reasons, including the administration of medications, injecting contrast dye for angiogram procedures, or removing small blood clots (thrombectomy) from veins and arteries. These devices are inserted into a blood vessel through a small puncture made in skin. Makers of these devices have issued multiple urgent safety recalls for millions of these devices due to reports that the devices are breaking and migrating.

As of 2015, one catheter maker, Cook, has issued recalls for all of its catheters that use its Beacon® Tip technology. These catheters are used to place contrast dye into blood vessels in the heart in preparation for cardiac angiograms. 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. Additionally, Cook has 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:

Slip-Cath Beacon Tip Catheter
Shuttle Select Slip-Catheter
Beacon Tip Torcon TB Advantage Cather
Beacon Tip Royal Flush Plus High-Flow Catheter
Beacon Tip Centimeter Sizing Catheter

Additionally, an FDA Class 1 Recall was issued for The Fetch 2 Aspiration Catheter because the catheter shafts are breaking at various points along the device during procedures. The catheter is used to remove small blood clots from peripheral veins and coronary arteries (thrombectomy) to restore blood flow to the heart. These failures can cause blockage of the blood supply to the heart or blood vessels and cause injury or death.

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