FDA Device recall Z-2749-2016
Pacemakers: Accolade MRI DR Model L311
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Pacemakers: Accolade MRI DR Model L311 by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2749-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-15 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | MA, MN, NH, PA, TX |
Product
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.
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.
Identifiers
| code_info | serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2749-2016%22
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