Recall Z-1607-2013 ยท NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
| Date | Jun 27, 2013 (initiated Jun 7, 2013) |
| Status | Terminated |
| Reason | Medtronic recently identified an issue with a subset of Consulta CRT-P and Syncra CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated June 7, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately return non-implanted devices to Medtronic and to register the implanted ones immediately by calling the Medtronic Patient Registration Department at 1-800-848-9300. Customers with questions were instructed to contact their local Medtronic representative or Medtronic Customer Service at 1-800-848-9300. For questions regarding this recall call 763-526-6000. UPDATE: An Urgent Medical Devi |
| Quantity | 1912 (159 USA & 1137 OUS) UPDATED: 1128 affected |
| Distribution | Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Leb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.