Pacemakers: Accolade MRI DR Model L311 — Class II medical device recall Z-2749-2016
Terminated recall by Boston Scientific Corporation, reported 2016-09-14, distributed in MA, MN, NH, PA, TX. Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shippe
| Recall number | Z-2749-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2016-06-15 |
| Classified | 2016-09-07 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-02-06 |
| Distributed | MA, MN, NH, PA, TX |
| Quantity | 5 |
| Serial numbers | 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, 710541 |
| Model numbers | L111, L311, L331 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2749-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.