ESSENTIO™ MRI DR L111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,790 adverse event reports that list this exact device (DI 00802526558962), received between Oct 11, 2016 and Sep 30, 2026 — classified as 9 deaths, 1,045 injuries, 736 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (632 reports).

2 FDA recall records name this device's identifier, 2 still open.

26 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-0082-2026 · Root cause: Other · Recall details · FDA record ↗

2. Dec 12, 2024Class IOpen, Classified

   A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

   Z-0824-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,790 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 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. Device replacement was recommended. No adverse patient effects were reported. This device remains in service at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947234 ↗
• MalfunctionSep 30, 2026Over-Sensing

  It was reported that the health care professional (HCP) requested Technical Services (TS) to review an Atrial Tachy Response (ATR) episode for this patient with this pacemaker, as it was thought that there was far field oversensing. TS agreed with this observation and discussed extending cross chamber blanking. This pacemaker remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946688 ↗
• InjurySep 30, 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. Device replacement was recommended. Subsequently this device was explanted, replaced, and returned for analysis. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946315 ↗
• MalfunctionSep 29, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940680 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925860 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918696 ↗
• InjurySep 25, 2026Data Problem

  It was reported that this pacemaker had an inaccurate implant date recorded. Technical Services (TS) stated the engineers were investigating this and noted the logbook and lead measurement dates were accurate. It was also noted that the patient would be seen in the clinic in approximately one week. No adverse patient effects were reported. This pacemaker remains in service.Additional information was received and it was reported that this pacemaker was explanted due to unknown reasons. No additional adverse patient effects were reported. This pacemaker was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897180 ↗
• 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. Device replacement was recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893816 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  It was reported that this pacemaker was explanted due to a Product Performance Issue. This pacemaker was successfully explanted and replaced with another device. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889771 ↗
• MalfunctionSep 23, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874049 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this pacemaker had swelling and possible infection. The patient fell and had a lump forming over the implant. There were no additional adverse patient effects reported. The pacemaker remains in service.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 50809503 ↗
• InjurySep 15, 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. This pacemaker was explanted, replaced with a different model, and will be returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773478 ↗
• MalfunctionSep 11, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741459 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741364 ↗
• MalfunctionSep 10, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724910 ↗
• MalfunctionSep 10, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722901 ↗
• MalfunctionSep 9, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702167 ↗
• InjurySep 9, 2026Premature Discharge of Battery; Insufficient Device Problem Information

  It was reported that this pacemaker was explanted due to an product performance issue. This pacemaker was successfully explanted and replaced with another device. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned for analysis.Additional information was received that this pacemaker was successfully explanted and replaced due to a Code 1003, indicative that the voltage was too low for projected remaining capacity upon interrogation. No adverse patient effects were reported. This product is expected to return.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699820 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679296 ↗
• InjurySep 8, 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; however, an official recommendation was not provided. This pacemaker was subsequently explanted. Another pacemaker was implanted to complete this procedure. This pacemaker has not been returned at this time. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673387 ↗
• MalfunctionSep 8, 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. Data analysis identified potential high impedance within the battery. Device replacement was recommended. The device remains in service. No adverse patient effects were reported.Additional information was provided that the patient was contacted regarding a recommended generator replacement based on Technical Services guidance, and advisory information was provided. The device replacement procedure has been scheduled. No adverse patient effects have been reported.Additional information was received indicating that the device was explanted. The product has not been returned for analysis. No additional adverse patient effects have been reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659594 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50657248 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651632 ↗
• MalfunctionSep 7, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650102 ↗
• InjurySep 4, 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 50612086 ↗

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-0097-2026 · Aug 20, 2025 · Open, Classified
  Model Number L131, ESSENTIO DR EL MRI Pacemaker
• Z-0084-2026 · Aug 20, 2025 · Open, Classified
  ACCOLADE DR EL MRI (Model L331)
• 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-0094-2026 · Aug 20, 2025 · Open, Classified
  Model Number L110, ESSENTIO SR SL MRI Pacemaker
• Z-0091-2026 · Aug 20, 2025 · Open, Classified
  Model Number L231, PROPONENT DR EL MRI Pacemaker
• Z-0089-2026 · Aug 20, 2025 · Open, Classified
  Model Number L211 PROPONENT DR SL MRI Pacemaker
• Z-0095-2026 · Aug 20, 2025 · Open, Classified
  Model Number L111, ESSENTIO DR SL MRI Pacemaker
• 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-1998-2021 · Jun 3, 2021 · Open, Classified
  Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
• Z-2000-2021 · Jun 3, 2021 · Open, Classified
  Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
• 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 11 more.