August 7, 2015 — Cook Medical has issued a Class I recall for about 95,000 catheter tips that can break, enter a patient’s bloodstream, and cause life-threatening complications.
Cook has received 26 reports of the Beacon-Tip catheters malfunctioning, with 14 cases resulting in serious injuries.
The company has received complaints of the catheter tip separating from the catheter, which may require emergency surgery to retrieve the fragment before it blocks blood-flow to organs. Tip splitting or separation may also cause the device to stop working.
The “Beacon Tip” catheters are long tubes that are used in a procedure known as coronary angiography. During this procedure, the catheter is inserted into the body through a small puncture in the skin and placed into a blood vessel in the heart. Contrast dye is injected into blood vessels and 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
The recalled catheters were sold between June 2013 and June 2015. The products can be identified by the part number and lot number on the outer package product label. For a list of products subject to recall, click here (PDF).
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