August 14, 2016
Cook Medical Issues Global Recall of Roadrunner UniGlide Hydrophilic Guidewires
August 15, 2016—Cook Medical announced that DSM Biomedical of the Netherlands, the supplier of Cook’s hydrophilic coating for the Roadrunner UniGlide hydrophilic guidewire, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. The Roadrunner device is intended for use in the delivery of percutaneous catheters into the peripheral vasculature.
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding, and embolic particulate in the circulatory system.
Cook advised that it received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide hydrophilic guidewires on June 24, 2016.
Cook Medical has not received any reports of adverse events of these types to date. The company is taking this action as a precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present in the coating of the recalled guidewire units.
Products in this recall were distributed globally and can be identified by the part number and lot number on the outer label of the package.
The US Food and Drug Administration (FDA) and other regulatory agencies around the world have been notified of this action.
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all recalled units and return the affected products to Cook as soon as possible for credit.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Adverse events may also be reported to Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235 or by email at CustomerRelationsNA@cookmedical.com.