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Cook Recalls Cardiac Catheters After 14 Injuries Reported

August 7, 2015 — A recall has been issued for over 95,000 cardiac catheters made by Cook Medical because the tip can break off inside a patient’s body.

Complete list of recalled products (PDF)

There have been 26 reports of the device malfunctioning, including 14 serious injuries. The FDA has classified the recall as Class I, meaning there is a reasonable probability that the device could cause death.

If the tip separates from the catheter, it can travel in the patient’s bloodstream, block blood-flow to organs, damage internal organs, or cause deadly complications. If the tip splits, it might also stop working.

The recalled “Beacon Tip” catheters are used to inject contrast dye during a cardiac angiography. The catheter is a long, flexible tube that is inserted though a hole in the patient’s skin to a blood vessel in the heart. After the contrast dye is injected, an X-ray is used to diagnose heart conditions.

Products included in the recall:

  • 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

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