Recall Z-0621-2016 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific Corporation
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
| Date | Jan 8, 2016 (initiated Dec 10, 2015) |
| Status | Terminated |
| Reason | The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker. |
| Root cause | Labeling mix-ups |
| Action | The firm, Boston Scientific, sent a "Medical Device Retrieval" letter dated December 2015 to its Consignees on 12/10/2015. The letter described the problem, product involved in the recall and actions to be taken. The consignees were instructed to immediately segregate the product to ensure that it will not be used, obtain an IAN (inventory authorization number) from Boston Scientific's Logistics Department by email at randall.peterfeso@bsci.com; return it back to Boston Scientific-Clonmel Cashel Rd., Clonmel Co Tipperary Ireland. If you have any questions about this retrieval contact your l |
| Quantity | 3 |
| Distribution | International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.