DSM coating possibly contaminated with glass particles leads to catheter recall

The possible presence of glass particles in a hydrophilic coating supplied by DSM Biomedical (Geleen, Netherlands) to Cook Medical (Bloomington, IN) for a line of guidewires has prompted the medical device manufacturer to initiate a recall. Cook reports on its website that it received one lot of the affected coating, which caused it to recall 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. It’s the third catheter-related recall for the company this year.

The glass particles range in size between 4 and 280 µm and could result in vessel damage, bleeding and the presence of blood clot particles in the circulatory system. Cook has not received any reports of adverse events related to the coating, but it says that it is taking this action as a precautionary measure, as it cannot exclude the possibility of these glass particles being present in the coating of the recalled devices.

Guidewires are metal instruments used to position catheters, among other devices, in the body. DSM Biomedical supplies its hydrophilic coatings to many medical device OEMs around the world to improve lubricity of the products and enhance patient comfort. When it became aware of the presence of glass particles during processing, DSM issued its own recall and alerted Cook Medical.

Cook customers and distributors, as well as FDA and other worldwide regulatory agencies, have been notified.

This recall is the latest setback for Cook Medical, reports Nancy Crotti in sister brand Qmed. In April, the company announced that it was voluntarily recalling about 4.1 million of its catheters because of complaints of the tips splitting or fracturing during procedures, and in February, it recalled more than 17,000 catheter kits for a similar problem.