Dutch coating supplier’s recall gives Cook Medical another headache

A Dutch supplier’s recall led to another headache for Cook Medical, already scrambling to recover from a massive catheter recall, when it prompted a partial recall of a wire guide used during peripheral vascular interventions.

The Bloomington, Ind.-based medical device giant said the supplier for the hydrophilic coating used on its Roadrunner Uniglide wire guides, Holland’s DSM Biomedical, recalled some product on concerns that it had been contaminated with glass particles ranging in size from 4µm to 280µm.

Cook, which said it received 1 lot of the affected coating, pulled 8,750 of the Roadrunner UniGlide June 24, despite receiving no reports of the types of injury related to the possible coating issue. No reports of any adverse events including vessel damage, bleeding and embolic particulate in the circulatory system were received, the company said.

All customers and distributors were notified of the recall by letter and the FDA and other global regulatory bodies were told, Cook said. Affected products should be quarantined and returned to the company for credit, it said. The list of recalled devices can be found here.

The catheter recall grew in April after Cook recalled about 4 million catheters made with its Beacon Tip locating technology, stemming from an increase in reports that the polymer used in the tips degrades over time, causing the tips to fracture or separate during procedures.

Cook Group president Pete Yonkman told MassDevice.com that the company 1st noticed the problem last year and initially recalled the smallest size Beacon Tip angiography catheter.

“Last year, we recalled our 4 French Beacon Tips, our smaller size of Beacon Tip catheters, because we were seeing this unexpected failure. It was a material degradation – you were seeing the material go from a pliable plastic to a harder material. The material was actually changing. We weren’t sure at the time what that was, but because we saw it in a sufficient rate, we recalled all the 4 French catheters,” Yonkman told us.

Further investigation by the company revealed what he called “clusters” of similar incidents in hospitals using whole-room sterilization procedures for their operating rooms, aiming to lower the rate of hospital-acquired, drug-resistant infections.

Yonkman said in May that he expected to have replacement catheters for the recalled Beacon Tip devices in the marketplace in 3 to 6 weeks.

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