11.18.13
Medtronic’s recent voluntary recall of some of its guidewires has now been classified by the U.S. Food and Drug Administration (FDA) as a Class I recall. 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.
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 cardiac device 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.
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 eight product lines that were manufactured after mid-April 2013: the Cougar nitinol workhorse guidewire; the Cougar steerable guidewire; the Zinger stainless steel workhorse guidewire; the Zinger steerable guidewire; the Thunder extra-support guidewire; the Thunder steerable guidewire; the ProVia crossing guidewire; and the Attain Hybrid guide wire.
The Minnesota, Minn.-based medical device company assured the public in a statement that it has taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.
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 cardiac device 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.
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 eight product lines that were manufactured after mid-April 2013: the Cougar nitinol workhorse guidewire; the Cougar steerable guidewire; the Zinger stainless steel workhorse guidewire; the Zinger steerable guidewire; the Thunder extra-support guidewire; the Thunder steerable guidewire; the ProVia crossing guidewire; and the Attain Hybrid guide wire.
The Minnesota, Minn.-based medical device company assured the public in a statement that it has taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.