Recall Z-1979-2013 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
| Date | Aug 16, 2013 (initiated Jul 15, 2013) |
| Status | Terminated |
| Reason | Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufactu |
| Root cause | Under Investigation by firm |
| Action | Consignee was sent on 7/15/13 a Boston Scientific "Medical Device Retrieval" letter dated July 12. 2013. The letter described the product problem and informed the consignee that they will replace the product removed from their inventory. For further questions, contact Boston Scientific Technical Services at 1 800 227-3422. |
| Quantity | 1 (4 devices were implanted and are not part of this action) |
| Distribution | US distribution in the state of Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.