Model note · Pacemaker
Boston Scientific ACCOLADE MRI pacemakers L310
ACCOLADE MRI is Boston Scientific's MR Conditional bradycardia pacemaker family, sold with ESSENTIO MRI and PROPONENT MRI variants and paired with INGEVITY leads as the ImageReady system. It offers rate adaptive pacing from an accelerometer, a minute ventilation sensor or a blend, and is programmed with the ZOOM LATITUDE programmer. Its recent history is dominated by battery related advisories, including hydrogen driven depletion and Safety Mode from high battery impedance.
The model
Maker, model and type.
- Maker
- Boston Scientific Corporation
- Model
- ACCOLADE MRI pacemakers L310 (SR), L311 (DR), L331 (DR EL), part of the ImageReady MR Conditional Pacing System
- Device type
- Pacemaker
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Family models (MRI) | ESSENTIO MRI L110, L111, L131; PROPONENT MRI L210, L211, L231; ACCOLADE MRI L310, L311, L331 | Source |
| Rate response sensors | Accelerometer, minute ventilation, or a blend of both | Source |
| MRI field (original approval) | 1.5 T only, about 64 MHz, horizontal closed bore, spatial gradient up to 50 T/m | Source |
| MRI SAR and gradient limits | Whole body 4.0 W/kg or less, head 3.2 W/kg or less, slew rate 200 T/m/s per axis or less, full body with no thoracic exclusion zone | Source |
| MRI Protection Mode | Dedicated scan mode with programmable time out for automatic exit after a chosen number of hours | Source |
| Companion lead | INGEVITY MRI leads (e.g. 7731, 7732, 7740 to 7742): 6 F, IS-1 bipolar, steroid eluting, IROX coated electrodes | Source |
| Programmer | ZOOM LATITUDE Programming System 3120 with software application 2869 | Source |
| FDA approval | PMA P150012, ImageReady MR Conditional Pacing System | Source |
Recalls
Known FDA recalls.
- Z-1770-20262026-03-19
Brady software maintenance release 6 available; advisory population widened to all CRT-P and DR EL devices.
FDA record - Z-0081-20262025-08-20
Software to stop ambulatory Safety Mode from high battery impedance (ACCOLADE SR SL MRI L310).
FDA record - Z-0822-20252024-12-12
Class 1: pre September 2018 builds may enter Safety Mode from latent high battery impedance.
FDA record - Z-2000-20212021-06-03
Hydrogen release may compromise a low voltage capacitor and accelerate battery depletion.
FDA record - Z-0358-20182017-12-07
Intermittent over sensing of the minute ventilation sensor signal (ACCOLADE MRI DR).
FDA record
Safety
Safety warnings from the record.
- MRI is allowed only at 1.5 T in a closed bore scanner under the listed SAR limits, with the patient supine or prone. Source
- Patients with raised body temperature or poor thermoregulation should not be scanned. Source
- During replacement of a device in Safety Mode, expect pacing inhibition when electrocautery is used. Source
Sources
Where this note comes from.
- FDA PMA P150012 Summary of Safety and Effectiveness Data, ImageReady MR Conditional Pacing System
- FDA recall Z-0822-2025, ACCOLADE DR
- FDA recall Z-2000-2021, ACCOLADE hydrogen battery depletion
- openFDA MAUDE problem counts, brand ACCOLADE MRI
Not covered: Longevity, battery chemistry, size and weight figures are in Boston Scientific's physician technical manual, which was not read. MRI conditions are from the original approval; later labelling may differ. Recalls for Stryker Accolade hip stems were excluded as a different product. MAUDE counts include clinical and lead reports and are not failure rates. The manufacturerUrl points to the FDA summary.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Pacemaker