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 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
Additional 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.
Contact:
Consumer:
(877) 526-7890
Media:
Joseph McGrath
(707) 591-7367
Jeff Warren
(763) 505-2696
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA:
Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or
Call FDA at +1-800-FDA-1088
http://www.fda.gov/Safety/Recalls/ucm375363.htm
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 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
Additional 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.
Contact:
Consumer:
(877) 526-7890
Media:
Joseph McGrath
(707) 591-7367
Jeff Warren
(763) 505-2696
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA:
Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or
Call FDA at +1-800-FDA-1088
http://www.fda.gov/Safety/Recalls/ucm375363.htm