ACCOLADE™ MRI SR L310Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,130 adverse event reports that list this exact device (DI 00802526559204), received between Jan 26, 2017 and Sep 30, 2026 — classified as 10 deaths, 729 injuries, 391 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (458 reports).

1 FDA recall record name this device's identifier, 1 still open.

27 other recalls cover devices cleared under the same FDA submission (P150012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 20, 2025Class IOpen, Classified

   Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

   Z-0094-2026 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950017 ↗
• InjurySep 28, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 50917016 ↗
• MalfunctionSep 25, 2026Premature Discharge of Battery

  It was reported that this pacemaker recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893086 ↗
• InjurySep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the pacemaker had entered the safety mode. Device replacement was recommended. This device remains in service. No adverse patient effects were reported.Additional information was received indicating that this device was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886502 ↗
• MalfunctionSep 18, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831018 ↗
• MalfunctionSep 18, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829478 ↗
• MalfunctionSep 18, 2026Interrogation Problem

  It was reported that during a clinic visit, the health care professional (HCP) reported being unable to read this pacemaker device data on the programmer. The HCP called Technical Services (TS) for troubleshooting assistance. TS verified the correct programmer was in use and walked the HCP through troubleshooting and rebooting efforts. The troubleshooting efforts were unsuccessful due to programmer was unable to interrogate the device. TS discussed possible causes and advised the HCP to contact the local field representative for further troubleshooting assistance. No adverse patient effects were reported. At this time, the pacemaker and programmer remain in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820617 ↗
• MalfunctionSep 16, 2026Use of Device Problem; Interrogation Problem

  It was reported that this pacemaker exhibited an alert message indicating that radio frequency (RF) telemetry was disabled. Analysis of device data was requested. Technical Services discussed that this was a false positive related to a software update and that all other device functions remain available. This pacemaker remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789857 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  It was reported that this pacemaker recorded a Code 1003, indicating the voltage was too low for the projected remaining capacity. A request was made to have data from this device analyzed. Technical Services (TS) recommended continued monitoring until Radio Frequency (RF) telemetry is disabled or device replacement is performed due to the remaining battery longevity. The patient will continue to be monitored. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731230 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50678894 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677050 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669231 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602314 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602299 ↗
• InjurySep 4, 2026Failure to Capture; High impedance

  It was reported that this pacemaker system exhibited high out of range pacing impedance measurements and loss of capture (LOC). This pacemaker was explanted and successfully replaced. No additional adverse patient effects were reported. This device is expected to be returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602215 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that this pacemaker was explanted due to unknown reasons. This pacemaker was successfully replaced, and no additional adverse patient effects were reported. This pacemaker has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602210 ↗
• MalfunctionSep 4, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602145 ↗
• InjurySep 4, 2026Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  It was reported that this pacemaker was unable to be interrogated and when it was examined, the pacemaker had entered Safety Mode. Additionally, some pauses on pacing delivery were reported. This pacemaker was subsequently explanted. A new pacemaker was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601425 ↗
• MalfunctionAug 24, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: Discomfort

  MAUDE report 50410427 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was reported that this pacemaker was explanted due to lead anomaly. This pacemaker lead was replaced and was returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 50410425 ↗
• InjuryAug 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this device was operating in Safety Mode. Technical Services (TS) was consulted and found an unknown code and submitted a request for an engineering analysis. TS recommended device replacement. The device was subsequently explanted, and a new device was successfully implanted. No additional adverse patient effects were reported. This device is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50266843 ↗
• InjuryAug 11, 2026Premature Discharge of Battery

  It was reported that this pacemaker recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. In addition, the device pacing was off. A request was made to have data from this device analyzed. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216512 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this pacemaker was part of a system revision due to infection. There was no additional adverse patient effects reported. The pacemaker was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50208511 ↗
• MalfunctionAug 6, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161444 ↗
• MalfunctionJul 31, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150012. One submission often covers many models, so check the product and lot details in each record.

• Z-1770-2026 · Mar 19, 2026 · Open, Classified
  Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL
• Z-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO DR SL MRI Pacemaker
• Z-0084-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR EL MRI (Model L331)
• Z-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT DR SL MRI Pacemaker
• Z-0091-2026 · Aug 20, 2025 · Open, Classified
  Model Number L231, PROPONENT DR EL MRI Pacemaker
• Z-0081-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE SR SL MRI (Model L310)
• Z-0088-2026 · Aug 20, 2025 · Open, Classified
  Model Number L210 PROPONENT SR SL Pacemaker
• Z-0097-2026 · Aug 20, 2025 · Open, Classified
  Model Number L131, ESSENTIO DR EL MRI Pacemaker
• Z-0082-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR SL MRI (Model L311)
• Z-0823-2025 · Dec 12, 2024 · Open, Classified
  PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
• Z-0822-2025 · Dec 12, 2024 · Open, Classified
  ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
• Z-0824-2025 · Dec 12, 2024 · Open, Classified
  ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
• Z-1998-2021 · Jun 3, 2021 · Open, Classified
  Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
• Z-1999-2021 · Jun 3, 2021 · Open, Classified
  Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
• Z-2017-2021 · Jun 3, 2021 · Open, Classified
  VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

…and 12 more.