Food Recalls (FDA)

FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall

Published on Saturday, 16 November 2013 01:42

FG_AUTHORS: FDA

Recall -- Firm Press Release FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall Contact:
Consumer:
(877) 526-7890Media:
Joseph McGrath
(707) 591-7367Jeff Warren
(763) 505-2696
 FOR IMMEDIATE RELEASE - MINNEAPOLIS – Nov. 15, 2013 – Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall.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 from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.The FDA defines a Class I recall 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 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 product lines that were manufactured after mid-April 2013:Cougar nitinol workhorse guidewireCougar steerable guidewireZinger stainless steel workhorse guidewireZinger steerable guidewireThunder extra-support guidewireThunder steerable guidewireProVia crossing guidewireAttain Hybrid guide wireAdditional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website – specifically,
http://www.medtronic.com/for-healthcare-professionals/index.htm.

Observations and consequences of the coating issue related to these guidewires should be reported to Medtronic in the United States by calling +1-877-526-7890 on weekdays from 8am to 5pm U.S. Central Time.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA:

ABOUT MEDTRONIC

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

 

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