Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc.,
FDA device recall Z-1200-2010 · posted 2010-03-23 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Managment
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DTB
- Quantity affected
- 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, Colomb
- Date initiated
- 2010-02-25
- Date posted
- 2010-03-23
- Date terminated
- 2012-01-07
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODELS 5069/5071 MYOCARDIAL PACING LEADS (K902002) | Medtronic Vascular | 1990-09-26 |