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August 3, 2015: Cook Medical Issues Recall For Beacon Tip Angiographic Catheter Products

The U.S. Food and Drug Administration (FDA) reports, that on July 2, 2015, Cook Medical issued a worldwide recall for 2,239 specific lots of its Beacon Tip Angiographic Catheters.

The products were recalled because the catheter tip has been found to slip or separate, resulting in adverse events in patients. To date, Cook has received 26 complaints of “catheter-tip splitting and/or separation.” Fourteen Medical Device Reports in which a tip split or separation occurred have been submitted to the FDA’s adverse event reporting program, known as “MedWatch.”

Catheter Product Recall Information:

The products subject to the recall include specific versions and lot numbers of the following Beacon Tip Angiographic Catheters:

  • Beacon Tip Torcon NB Advantage Catheters (Catalog Prefix HNBR5.0)
  • Beacon Tip Royal Flush Plus High-Flow Catheters (Catalog Prefix HNR4.0)
  • Slip-Cath Beacon Tip Catheters (Catalog Prefix SCBR5.0).

The recalled Beacon Tip Angiographic Catheters were distributed between June 2013 and June 2015. According to a company press release, the product can be identified by “the part number and lot number provided on the outer package product label.” The lot numbers for products that are subject to this recall can be found at .

The company has instructed its customers to immediately quarantine unused products from their inventory. Healthcare professional and patients can report adverse events and side effects related to the use of these products online to the FDA at MedWatch.

About Angiographic Catheters

Beacon Tip Angiographic Catheters are medical devices used to inject contrast dye in blood vessel in the heart in preparation for a type of x-ray used to diagnose heart conditions. A small incision is made in the skin to insert the catheter into the blood vessel along a guide wire before injecting the contrast dye.

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