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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

Latest Defective Catheter Takes Its Place in Long Line of FDA Recalls
Latest Defective Catheter Takes Its Place in Long Line of FDA Recalls Silver Spring, MD: When it comes to defective catheters causing injury, Bard Peripheral Vascular's recall of its Halo One Thin-Walled Guiding Sheath is the latest in a long line of catheter recalls that include the Boston Scientific Corp. Fetch 2 Aspiration Catheter and Cook Medical's Shuttle Select Slip-Catheter and Beacon catheters [READ MORE]

Catheter Recalls Number into the Millions. Will Lawsuits Follow?
Catheter Recalls Number into the Millions. Will Lawsuits Follow? Washington, DC: With some four million allegedly defective catheters having been recalled from the market, such a number extrapolated across risk factors suggest defective catheters causing injury lawsuits will result, given the number of fairly common medical procedures for which catheters are routinely employed [READ MORE]

Recalls Over Catheter Fragments Increasing, More Manufacturers Involved
Recalls Over Catheter Fragments Increasing, More Manufacturers Involved Dallas, TX: Catheters are devices of varying sizes designed for insertion into the body in order to facilitate a wide variety of treatments. They are designed to unobtrusively perform their respective functions and tasks, followed by extraction without any lingering sign the catheters had been there in the first place. However, various reports of defective catheters causing injury, together with a rash of recalls, suggest catheters are not living up to their role as an invisible sentry [READ MORE]



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