DSM Biomedical, which supplies Cook Medical’s hydrophilic coating for Cook Medical’s Roadrunner Uniglide, has recalled certain lots of material due to concerns over a potential contamination by glass particles ranging in size of around 4µm to 280µm.
Roadrunner UniGlide has been developed for use in the delivery of percutaneous catheters into the peripheral vasculature.
Around 8,750 units of the Roadrunner UniGlide hydrophilic wire guides have been recalled, as Cook received one lot of the affected recalled coating.
Adverse events expected to occur due to contamination include vessel damage, bleeding and embolic particulate in the circulatory system.
Cook said that it has not received any reports of adverse events of these types to date.
Thec ompany has informed customers and distributor to isolate and discontinue the use of recalled units and return the affected products to it for credit.
In May, Cook Medical also initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology.
Catheters with Beacon Tip technology were found to exhibit polymer degradation of the catheter tip, resulting in tip fracture or separation.
Catheters with Beacon Tip technology are intended for use by physicians who are trained and experienced in each of the procedures for which these devices are indicated for use.
Image: Cook Medical Roadrunner Uniglide hydrophilic wire guide. Photo: © Cook.
