Cook Medical Hit with Major Catheter Recall

The recall involves 17,827 devices globally and involves potential catheter tip fracture and/or separation.

Nancy Crotti

Cook Medical has issued the second major catheter recall due to tip splitting or separation since July 2015.

The voluntary recall by the Bloomington, IN-based company involves 360 lots of single lumen central venous catheters and pressure monitoring sets and trays, or 17,827 devices globally, due to the potential for catheter tip fracture and/or separation.

The devices were distributed between April 24, 2015 and October 23, 2015.Cook said it began notifying customers January 6. FDA had not yet classified the recall.

"Although there have been no reports of illness or injury associated with this issue to date, upgrading to a Class I recall expands our efforts to hasten the return of recalled products and minimize potential patient risk," the company said in an email to Qmed.

An internal company inspection revealed the potential for breakage or separation, according to a company press release distributed by FDA. Upon further investigation, the company found that the technique used by the product assembler while adding the tip to the catheter likely contributed to the problem.

Should the tip break or separate, the catheter could stop working or trigger medical intervention to retrieve a broken piece. Potential consequences include stroke, kidney injury, or damage to the intestines or limbs. No injuries have been reported, the company statement said.

Cook marketed the recalled products for venous or arterial pressure monitoring, blood sampling, and administering drugs and fluids. The recall includes specific versions and lot numbers of the single lumen central venous catheter sets and trays, single lumen pressure monitoring sets, femoral artery pressure monitoring catheter sets and trays, and radial artery pressure monitoring cathetersets and trays. Lot numbers are available in the company press release.

In August 2015, FDA issued a Class I designation for a different recall of 95,167Cook Medical Beacon tip angiographic catheters worldwide. The company had received 26 complaints of catheter-tip splitting and/or separation by the time the FDA issued its classification, and 14 medical device reports.

In July 2014, Cook Medical recalled nearly 700 of its CloverSnare 4-Loop Vascular Retrieval Snares in the U.S. due to danger of serious injury or death because a loop separating from a shaft could block blood vessels or become stuck in the heart or lungs.

The snare is used to manipulate and retrieve items in the cardiovascular system, such as temporary implanted devices and even broken guidewires, coils, balloons, and catheters.

Nancy Crotti is a contributor to Qmed and MPMN.

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