The FDA issued a Class I recall on Medtronic guidewires used in PCIs and in the placement of left ventricular leads for cardiac rhythm devices.
Minneapolis-based Medtronic is notifying hospitals and distributors that the coating on the surface of some models of guidewires may delaminate and detach. The company said it received some complaints, including one that involved patient injury. It advised customers to quarantine the recalled guidewires and return them to the company for replacement or credit.
The affected guidewires were manufactured after mid-April 2013 under the following product lines:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guidewire