[Posted 11/15/2013]

AUDIENCE: Health Professional, Cardiology, Risk Management

ISSUE: Medtronic, Inc.announced that FDA has classified the company's recently initiated voluntary field action related tocertain guidewire. Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires fromrecent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that allpotentially affected units be quarantined immediately and returned to the company as soon as possible for credit andreplacement.

BACKGROUND: The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight productlines that were manufactured after mid-April 2013:

• 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 guide wire

RECOMMENDATION: Additional information about the recall, including the lot numbers of affected product, is accessible throughthe Medtronic website specifically, Http://www.medtronic.com/for-healthcare-professionals/index.htm1.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of theseproducts 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

11/15/2013 - [Firm Press Release]