ESSENTIO™ DR L101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,112 adverse event reports that list this exact device (DI 00802526558924), received between Apr 15, 2016 and Sep 24, 2026 — classified as 3 deaths, 611 injuries, 498 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (293 reports).

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

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, 2025Open, 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-0080-2026 · Root cause: Other · Recall details · FDA record ↗

2. Dec 12, 2024Open, 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 1,112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889463 ↗
• MalfunctionSep 23, 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 50870330 ↗
• MalfunctionSep 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. 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 50797185 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735497 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659141 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656116 ↗
• InjuryAug 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was interrogated and found to be in safety mode. Technical Services (TS) recommended device replacement. Subsequently, this pacemaker was explanted and successfully replaced. 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 50310229 ↗
• InjuryAug 18, 2026Insufficient Device Problem Information

  It was reported that this pacemaker was explanted due to an advisory and recall. 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 50291241 ↗
• MalfunctionAug 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168793 ↗
• InjuryJul 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. 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 50090910 ↗
• MalfunctionJul 13, 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 25803753 ↗
• MalfunctionJul 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS DISABLED (RMD) AND LATITUDE WAS NO LONGER ABLE TO MONITOR THIS PATIENT'S PACEMAKER DEVICE DUE TO LIMITED BATTERY CAPACITY. UPON REVIEW, TECHNICAL SERVICES (TS) STATED THAT REMOTE MONITORING DISABLED ON (B)(6) 2026 DUE TO LIMITED BATTERY CAPACITY AND THE EXPLANT INDICATOR REACHED ON (B)(6) 2000. TS STATED THAT IT WAS LIKELY THAT THIS WAS A FALSE RMD TRIGGER DUE TO MAGNET APPLICATION DURING THE LOADED BATTERY MEASUREMENT AS THIS BATTERY HAS NOT YET REACHED 50% OF THE ERI CAPACITY. TS RECOMMENDED SMR6 WHICH WILL RESTORE FULL TELEMETRY FUNCTION TO SUCH UNITS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717612 ↗
• InjuryJul 1, 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. DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE STILL REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681196 ↗
• InjuryJun 30, 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. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED. ANOTHER DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE. THIS DEVICE HAS NOT BEEN RETURNED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673428 ↗
• InjuryJun 22, 2026Use of Device Problem; Data Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED AN ALERT INDICATING THAT REMOTE MONITORING (RMD) WAS NO LONGER AVAILABLE DUE TO LIMITED BATTERY CAPACITY, WITH AN EXPLANT INDICATOR DISPLAYING A DATE OF (B)(6) 2000. TECHNICAL SERVICES (TS) REVIEWED THE INFORMATION AND DETERMINED THIS IS LIKELY A FALSE POSITIVE TRIGGER, POTENTIALLY RELATED TO MAGNET APPLICATION DURING A BATTERY MEASUREMENT, AS THE DEVICE HAS NOT REACHED THE EXPECTED ELECTIVE REPLACEMENT INDICATOR (ERI) THRESHOLD. TS NOTED THAT THIS BEHAVIOR MAY BE RESOLVED WITH THE APPLICABLE SOFTWARE UPDATE, WHICH RESTORES FULL TELEMETRY FUNCTIONALITY AND THE PLAN IS TO FURTHER EVALUATE ON THE NEXT IN-CLINIC VISIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. AT THIS TIME, THIS PRODUCT HAS BEEN RETURNED AND THE ANALYSIS IS BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586437 ↗
• MalfunctionJun 18, 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. 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 25550613 ↗
• InjuryJun 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. 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 25538510 ↗
• MalfunctionJun 12, 2026Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXHIBITING INTERMITTENT LOSS OF CAPTURE (LOC) AND NOISE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD, WITH NO ASYSTOLE GREATER THAN TWO SECONDS REPORTED. A RIGHT VENTRICULAR LEAD REVISION HAD BEEN PLANNED; HOWEVER, DURING PREPARATION FOR THE PROCEDURE, ADDITIONAL NOISE WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD, RESULTING IN CANCELLATION OF THE PROCEDURE PER PHYSICIAN DISCRETION. IT WAS FURTHER REPORTED THAT THE PATIENT WILL BE REFERRED FOR EXTRACTION OF BOTH LEADS AND IMPLANTATION OF A NEW SYSTEM. TECHNICAL SERVICES (TS) REVIEWED THE AVAILABLE DATA AND INDICATED THAT NOISE WAS NOT OVERSENSED ON THE PRESENTING RV ELECTROGRAM; HOWEVER, FINDINGS WERE CONSISTENT WITH RV LOSS OF CAPTURE, WITH EVIDENCE SUGGESTIVE OF INTRINSIC VENTRICULAR ESCAPE RHYTHM. TS ALSO NOTED THAT NO RA LEAD NOISE WAS OBSERVED ON THE PRESENTING ELECTROGRAM. AS OF THIS TIME, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488753 ↗
• MalfunctionJun 10, 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. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. DEVICE REPLACEMENT WAS RECOMMENDED. THE CLINIC SCHEDULED A DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461050 ↗
• InjuryJun 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER REVERTED TO SAFETY MODE. THE PATIENT WAS REPORTED TO FEEL UNWELL. TECHNICAL SERVICES (TS) WAS CONTACTED AND REVIEWED THE DATA AVAILABLE. THIS PACEMAKER WAS SUBSEQUENTLY EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 25461033 ↗
• MalfunctionJun 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. 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 25429726 ↗
• MalfunctionJun 5, 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 EXPLANT INDICATOR RELATED TO A SOFTWARE UPDATE AND THAT ALL OTHER DEVICE FUNCTIONS REMAIN AVAILABLE. THIS DEVICE SOFTWARE WAS UPDATED, AND RF FUNCTION WAS RESTORED. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414207 ↗
• MalfunctionJun 1, 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. 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 25350653 ↗
• InjuryMay 29, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; High Capture Threshold

  IT WAS REPORTED THAT DURING A ROUTINE VISIT; THIS PACEMAKER SYSTEM WAS FOUND TO BE OPERATING IN SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONTACTED FOR CONSULT REVIEW. TS REVIEWED PROVIDED STORED REPORTS AND CONFIRMED DEVICE TO BE IN SAFETY MODE. TS ALSO NOTED THAT A PRIOR CONSULT REPORT FROM (B)(6) 2024 SHOWED RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) WAS DETECTED AS GREATER THAN PROGRAMMED AMPLITUDE OR SUSPENDED. FURTHER REVIEW SHOWED HIGH PACING THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. TS ADVISED THAT CHANGEOUT URGENCY SHOULD BE DRIVEN BY POTENTIAL SYMPTOMS TO CURRENT SETTINGS AND INCREASE IN POWER CONSUMPTION DUE TO INCREASE IN PACING OUTPUT VOLTAGE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS PROVIDED THAT REPORTED THAT A REPLACEMENT PROCEDURE WAS PERFORMED. THE PACEMAKER WAS EXPLANTED DUE TO SAFETY MODE AND PREMATURE BATTERY DEPLETION (PBD) AND REPLACED WITH A NEW DEVICE SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340677 ↗
• MalfunctionMay 13, 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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162922 ↗