Recall Z-1200-2010 ยท DTB Permanent Pacemaker Electrode
Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico.
| Date | Mar 23, 2010 (initiated Feb 25, 2010) |
| Status | Terminated |
| Reason | Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect product sterility. |
| Root cause | Packaging |
| Action | Consignees were sent a Medtronic "Important Medical Device Recall" Letter dated February 2010 on 2/25/10. The letter described the problem and the product. Medtronic recommended to immediately remove the affected leads from inventory. Customers with questions, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-505-4636. |
| Quantity | 4,863 (US); 6,328 (OUS) |
| Distribution | All States in continental USA including DC except Alaska. OUS: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, E |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902002 | MODELS 5069/5071 MYOCARDIAL PACING LEADS Medtronic Vascular, Sep 26, 1990 |