Medtronic Launches Cardiac Device Guidewire Recall

Eight Product Lines Affected By Announcement

20.11.2013

Medical technology firm Medtronic has announced a recall of some of its models of guidewires which are used as part of cardiac devices.

The company has confirmed that following an internal investigation it has been notifying hospitals and worldwide distributors that some models from recent lots have the potential for the coating on the surface to both delaminate and detach.

Medtronic called on all potentially affected units to be quarantined and returned to the company as soon as possible, with the US Food and Drug Administration subsequently classifying the action as a Class I recall.

The eight affected product lines were manufactured after mid-April 2013 and are:

  • Cougar nitinol workhorse guidewire
  • Cougar steerable guidewire
  • Zinger stainless steel workhorse guidewire
  • Zinger steerable guidewire
  • Thunder extra-support guidewire
  • ProVia crossing guidewire
  • Attain Hybrid guidewire

Additional information on the specific affected lot numbers is now available from the Medtronic website.