ESSENTIO™ EL DR L121Recalls & reported problems
Boston Scientific Corporation · Pacemaker · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Boston Scientific Essentio pacemaker is an implanted device that paces the heart. Its 725 reports often describe the battery running down early, high battery impedance and sensing problems. The reports mention no deaths and 379 injuries, and reports rose from 57 in the prior 12 months to 127 in the latest 12 months. There are 2 open recalls, both about the device entering safety mode because of high battery impedance.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 758
- Deaths reported
- 0
- Injuries reported
- 381
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 758 adverse event reports that list this exact device (DI 00802526558986), received between Apr 21, 2016 and Sep 30, 2026 — classified as 381 injuries, 377 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (356 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.
Reports received per month
Recalls naming this device
- 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-0083-2026 · Root cause: Other · Recall details · FDA record ↗
- 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
Device problems
- Premature Discharge of Battery356
- High impedance130
- Over-Sensing126
- Defective Device90
- Battery Problem77
- Signal Artifact/Noise55
- Pacing Problem54
- Ambient Noise Problem45
Patient problems
- No Clinical Signs, Symptoms or Conditions474
- No Known Impact Or Consequence To Patient155
- No Consequences Or Impact To Patient33
- No Code Available32
- Unspecified Infection30
- Insufficient Information18
- Syncope15
- Sepsis14
Recent adverse event reports
The 25 most recent of 758 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 50948572 ↗MalfunctionSep 24, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890352 ↗MalfunctionSep 23, 2026Premature Discharge of Battery; Nonstandard Device; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872286 ↗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. 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 50870462 ↗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 and showed the battery appeared to be depleting more quickly than expected. Technical Services (TS) recommended continued monitoring. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868271 ↗MalfunctionSep 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. 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 50819962 ↗MalfunctionSep 16, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796153 ↗MalfunctionSep 16, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795640 ↗MalfunctionSep 16, 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 50790883 ↗MalfunctionSep 11, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741419 ↗MalfunctionSep 8, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Off-Label Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680188 ↗MalfunctionSep 8, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674127 ↗MalfunctionSep 7, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656682 ↗MalfunctionSep 7, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50644451 ↗MalfunctionSep 4, 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 50602459 ↗MalfunctionSep 4, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50602159 ↗MalfunctionSep 2, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569227 ↗MalfunctionAug 19, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326238 ↗MalfunctionAug 19, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326237 ↗MalfunctionAug 18, 2026Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291917 ↗MalfunctionAug 17, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50284786 ↗MalfunctionAug 14, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254247 ↗MalfunctionAug 11, 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 50205337 ↗MalfunctionAug 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. 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 50189716 ↗MalfunctionAug 6, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166015 ↗
Other Implantable pulse generator, pacemaker (non-CRT) devices
- Assurity MRI™ PM2272St. Jude Medical, Inc. · Implantable pulse generator, pacemaker (non-CRT)1 recall264 deaths16,996 reports
- ACCOLADE™ MRI EL DR L331Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls22 deaths7,984 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)187 deaths7,655 reports
- ACCOLADE™ MRI DR L311Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls59 deaths7,283 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)107 deaths5,971 reports
- ACCOLADE™ DR L301Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls6 deaths2,513 reports
- ACCOLADE™ EL DR L321Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls2 deaths1,906 reports
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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