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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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DEFECTIVE PRODUCTS LEGAL ARTICLES AND INTERVIEWS

Catheter Injury Lawsuits following Catheter Recalls
Catheter Injury Lawsuits following Catheter Recalls Dallas, TX: In the wake of more than four million catheter recalls over the past year by numerous medical device manufacturers, dozens of patients have reported injuries and two wrongful death lawsuits have been filed due to broken catheters [READ MORE]

Will Federal Deregulation make it Easier for Plaintiffs to Sue over Defective Catheters?
Will Federal Deregulation make it Easier for Plaintiffs to Sue over Defective Catheters? Washington, DC: We are just a few days beyond the one-year anniversary of the issuance, by the US Food and Drug Administration (FDA), of a Class 1 designation to the recall of the Fetch 2 Aspiration Catheter by medical device manufacturer Boston Scientific. The voluntary recall was triggered by the manufacturer the previous month, on March 22, 2016 [READ MORE]

FDA Issues Recall on Medtronic Implantable Pain Pumps
FDA Issues Recall on Medtronic Implantable Pain Pumps Silver Spring, MD: Six months after Medtronic issued a voluntary recall on certain potentially defective catheters, the Federal Drug Administration has announced an update on a previous recall on two of Medtronic's implantable drug pumps [READ MORE]



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