ESSENTIO™ MRI SR L110Recalls & reported problems

Summary

The FDA's MAUDE database contains 467 adverse event reports that list this exact device (DI 00802526558948), received between Oct 12, 2016 and Sep 30, 2026 — classified as 2 deaths, 336 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (278 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 16, 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-0081-2026 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 467 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 50952735 ↗
• MalfunctionSep 30, 2026Use of Device Problem; Data Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949690 ↗
• MalfunctionSep 23, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876273 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651419 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50569720 ↗
• MalfunctionAug 21, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379497 ↗
• InjuryAug 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  It was reported that this pacemaker was explanted due to unknown reasons. Additional information was requested but unable to be obtained at this time. 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 50374490 ↗
• InjuryAug 21, 2026High impedance

  It was reported that this pacemaker exhibited high out of range pace impedance measurements. Technical Services (TS) was consulted and recommended evaluating the threshold with a programmer and to look for possible connection issues. An engineering analysis was conducted, and TS confirmed the out of range measurements, furthering discussing with the local field representative and further recommended turning off Trend mode. The device was used as a temporary pacing device and was subsequently explanted. A new pacemaker was successfully implanted. No additional adverse patient effects were reported. This pacemaker is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50370188 ↗
• InjuryAug 17, 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. Additional information was received indicating that this device was explanted and replaced. No additional adverse patient effects were reported, and this device has not been returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288799 ↗
• MalfunctionAug 10, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196783 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50105275 ↗
• MalfunctionJul 31, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100420 ↗
• InjuryJul 30, 2026Premature Discharge of Battery

  It was reported that this pacemaker was explanted due to potential premature battery depletion. This pacemaker was replaced successfully. This device has not been received for investigation. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50093610 ↗
• MalfunctionJun 29, 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 25659514 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25404354 ↗
• DeathJun 1, 2026Pacing Problem; Insufficient Device Problem Information

  It was reported the pacemaker patient passed away on (b)(6) 2026. The patient's daughter stated that the pacemaker "failed to work". Technical Services discussed that if the patient had damage to the myocardium the ability to pace may have been compromised. In addition, if the patient had a fast arrhythmic event the pacemaker doesn't treat that. The patient was cremated, and it is unknown if the pacemaker will be returned. The daughter stated that she would reach out to the doctor's office.It was additionally reported that that the patient had been on dialysis at the time of death. The pacemaker had been set with a lower rate limit of 40 beats/minute; however, monitors had been displaying 30 beats/minute which was possibly misinterpreted. Despite good faith effort, no further details were obtained regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349933 ↗
• MalfunctionMay 14, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE 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. THE DEVICE STILL REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167088 ↗
• InjuryMay 7, 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. TECHNICAL SERVICES (TS) RECOMMENDED TO EITHER SCHEDULE A REPLACEMENT PROCEDURE WITHIN 28 DAYS OR CONTINUE MONITORING UNTIL RADIO FREQUENCY (RF) TELEMETRY IS DISABLED, AFTER WHICH, DEVICE REPLACEMENT IS ADVISED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115679 ↗
• MalfunctionApr 30, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO PACING IMPEDANCE MEASUREMENTS OUT OF RANGE. IT WAS NOTED THAT THERE WAS MYOPOTENTIAL NOISE AFTER THE LSS SINCE THE DEVICE WAS UNIPOLAR PACING AND SENSING. THIS CAUSED THE PATIENT TO EXPERIENCED ASYSTOLE SINCE THERE WAS PACING INHIBITION. TECHNICAL SERVICES (TS) RECOMMENDED THOROUGH LEAD EVALUATION IN BIPOLAR AND UNIPOLAR WITH ISOMETRICS AND SERIAL IMPEDANCES. THIS PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 25053097 ↗
• MalfunctionApr 21, 2026Use of Device Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED AN ALERT MESSAGE INDICATING THAT REMOTE MONITORING WAS DISABLED. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED STEPS FOR RE-ENABLING REMOTE MONITORING AND THIS WAS RESOLVED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944634 ↗
• MalfunctionApr 17, 2026Use of Device Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED AN ALERT MESSAGE INDICATING THAT REMOTE MONITORING WAS DISABLED. TECHNICAL SERVICES (TS) WAS CONSULTED AND DETERMINED THAT THIS WAS LIKLEY A FALSE POSITIVE INDICATOR RELATED TO A SOFTWARE UPDATE. TS INDICATED THAT FULL TELEMETRY FUNCTION COULD BE RESTORED VIA A SOFTWARE UPDATE. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916461 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24867488 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF THE SYSTEM REVISION DUE TO BACTEREMIA. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 24722776 ↗
• MalfunctionMar 26, 2026High impedance; Connection Problem

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM, IMPLANTED WITH A NON BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD, EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THIS BEHAVIOR APPEARED CONSISTENT WITH A SPRING CONTACT ISSUE. THIS PACEMAKER SYSTEM REMAINS IN SERVICE, AND WILL CONTINUE TO BE MONITORED FOR ANY CHANGES IN IMPEDANCE TRENDS OR NOISE THAT MAY DEVELOP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706574 ↗
• MalfunctionMar 6, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS PACEMAKER WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536521 ↗

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-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-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-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-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-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-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)
• 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

…and 12 more.