Class I Recall of Medtronic Cardiac Guidewire After FDA Investigation Reveals Complaints
On November 15, 2013, Medtronic issued a press release announcing a recall of certain cardiac guidewires, which has been classified by the FDA as a Class I Recall. A Class I Recall is defined as “a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
The recalled cardiac guidewires are constructed to enable percutaneous coronary interventions or placement of left ventricular leads for cardiac rhythm devices. Medtronic issued the recall as a result of an internal FDA investigation that prompted a number of complaints, including one injury. According to the FDA, on October 21, 2013, Medtronic began notifying hospitals and distributors that some models of its guidewires have the potential for the coating on their surface to delaminate and detach. As a result, Medtronic requested in its recall that all potentially affected units be returned to the company immediately for replacement.
The recall includes specific lots of cardiac guidewire manufactured after April 2013 for the following eight product lines:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidwire
- ProVia crossing guidewire
- Atlain Hybrid guide wire
Additional information concerning the recall is available through the Medtronic website, including particular lot numbers for the affected products at issue.
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