UPDATED 06/25/2014. Recall classified as Class I.
AUDIENCE: Risk Manager, Cardiology, Radiology
ISSUE: NDC issued a recall of all HydroFinity Hydrophilic Guidewires due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. Vessel occlusion may necessitate surgical intervention to resolve. Two cases were reported where the polymer jacket separated from the device and embolized. One case required surgical intervention.
BACKGROUND: The HydroFinity Guidewire is a product developed and manufactured by NDC and distributed by Covidien. It is a nitinol-core, polymer-jacketed guidewire with a hydrophilic coating intended for use in catheter placement and other procedures to treat vascular diseases.
RECOMMENDATION: Covidien alerted customers by letter on June 3, 2014 and is recalling all product. Unused product should be returned to Covidien.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178