The FDA is recalling guidewires used in catheter procedures because the coating may flake off. The agency warned that use of the guidewire could have serious adverse consequences.
The guidewire fits inside a percutaneous catheter and is used in various surgical convenience kits assembled and marketed by Medline Industries.
The FDA encouraged risk managers to inspect their inventory for convenience kits containing ACME Monaco Guidewire .035x150 3 MMJ TCFC, item number 88241. Product codes included in this recall are 054372-1-1A, 054372-1-1B, and 054372-1-2A. The affected products were distributed from March through August 2013.
Managers and physicians should remove the affected guidewires and return them to Medline. They can replace the guidewire with a sterile product and use the rest of the kit. Physicians should inform the FDA if their patients experience any adverse events or side effects from the guidewire.