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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

Unnecessary and Defective Catheter?
Unnecessary and Defective Catheter?
November 4, 2017
Santa Clara, CA: The number of catheters reported to be defective over the last few years is mind-boggling. Over the past year alone several medical device manufacturers have recalled a combined four million catheters. Why so many? A study published yesterday may give one explanation [READ MORE]

The Recalled Fetch 2 Aspiration Catheter Received FDA 510(k) Clearance
The Recalled Fetch 2 Aspiration Catheter Received FDA 510(k) Clearance
October 8, 2017
Washington, DC: When the Fetch 2 Aspiration Catheter was originally launched by Bayer Medical Care Inc., (Bayer), there was no shortage of platitudes which, sometime later presented as a stark contrast to the eventual global recall that resulted in many a lawsuit amidst allegations of defective catheters causing injury [READ MORE]

Why so many Catheters Recalled?
Why so many Catheters Recalled?
September 27, 2017
Santa Cruz, CA: Another catheter was recalled last week, and this one got a Class 1 recall category, meaning the most serious kind [READ MORE]



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