Recall Z-2749-2016 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific Corporation
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
| Date | Sep 7, 2016 (initiated Jun 15, 2016) |
| Status | Terminated |
| Reason | Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet. |
| Root cause | Process control |
| Action | As we considered the value of a direct physician communication we have not identified any information that would be of value to the physician because device performance and behavior remain unchanged. |
| Quantity | 5 |
| Distribution | Distributed to the states of TX, NH, MA, PA, and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.