Recall Class: Class I
Date Recall Initiated: October 21, 2013
Cougar Nitinol Workhorse Guidewire
Cougar Steerable Guide wire
Zinger Stainless Steel Workhorse Guidewire
Zinger Steerable Guide wire
Thunder Extra-Support Guidewire
Thunder Stet Delivery System
ProVia Crossing Guidewire
Attain Hybrid Guidewire
These recalled products were manufactured from April, 2013 through September, 2013 and distributed from May, 2013 through October, 2013.
Use: Medtronic steerable guide wires are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
37A Cherry Hill Drive
Danvers, MA 01923
CEA Global Dominicana
Zona Franca Industrial
San Pedro De Macoris
Reason for Recall: There is a potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from guide wire. Medtronic steerable guide wires are used to aid in the placement of ventricular leads in the coronary vasculature. Use of this recalled product may result in serious adverse health consequences.
Public Contact: For questions about this recall, contact Medtronic Lifeline Technical Support at 1-877-526-7890 Monday through Friday, 8 AM through 5 PM Central Standard Time.
FDA District: New England District Office
FDA Comments: On October 21, 2013, Medtronic sent “Urgent Medical Device Notification Letters ” to all affected customers via UPS overnight service. The letter requested customers not to use and return the potentially affected guide wires to Medtronic. Additionally, the firm requested customers complete the Customer Confirmation Certificate and fax it to Medtronic at 1-651-367-0612 to the attention of: Customer Focused Quality.
Healthcare Professionals: Medtronic is requesting the return of all unused potentially affected guide wires to Medtronic. These actions are not expected to cause a device shortage.
Customers can contact Medtronic Lifeline Technical Support at 1-877-526-7890 Monday through Friday, 8 AM through 5 PM Central Standard Time.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.