ACCOLADE™ EL DR L321Recalls & reported problems
Boston Scientific Corporation · Pacemaker · Class 3 · Implant
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Boston Scientific Accolade pacemaker has 1,827 adverse event reports on record, including 2 deaths and 1,086 injuries. Many reports describe the battery running down faster than expected, and some describe the pacemaker switching into a protective fallback mode, sometimes leading to its removal. Two open recalls name this device, both about high battery resistance that may trigger that fallback mode, with a software update available for one. Reports rose to 346 in the last 12 months, from 201 in the year before.
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
- 1,906
- Deaths reported
- 2
- Injuries reported
- 1,099
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,906 adverse event reports that list this exact device (DI 00802526559242), received between Apr 22, 2016 and Sep 30, 2026 — classified as 2 deaths, 1,099 injuries, 805 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (902 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. How this data works · Data updated Oct 13, 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-0096-2026 · Root cause: Other · 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-0822-2025 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Premature Discharge of Battery902
- Over-Sensing273
- High impedance270
- Battery Problem214
- Defective Device195
- Adverse Event Without Identified Device or Use Problem140
- Signal Artifact/Noise140
- Pacing Problem133
Patient problems
- No Clinical Signs, Symptoms or Conditions1,158
- No Known Impact Or Consequence To Patient338
- Unspecified Infection116
- No Code Available86
- No Consequences Or Impact To Patient71
- Insufficient Information64
- Syncope34
- Sepsis33
Recent adverse event reports
The 25 most recent of 1,906 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. 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 50948571 ↗MalfunctionSep 30, 2026High impedance
It was reported that this pacemaker and the right ventricular (RV) lead exhibited a Red Call Doctor Icon (RCD). The RCD was recorded due to a high out of range pacing impedance measurement, greater than 3000 Ohms. This pacemaker remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946995 ↗MalfunctionSep 30, 2026Premature Discharge of Battery; Battery Problem
It was reported that the implantable pacemaker device suspected premature battery depletion (PBD) and longevity dropped from 4.5 years to 2.5 years in a span of 3 months. Boston Scientific Technical Services (TS) discussed device appears to be operating as expected and the battery measurements are rounded down which can make it appear to be depleting faster than expected. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943566 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941392 ↗InjurySep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926607 ↗InjurySep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918987 ↗MalfunctionSep 28, 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 50917388 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915008 ↗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. 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 50896963 ↗InjurySep 25, 2026Insufficient Device Problem Information
It was reported that this pacemaker exhibited a nonspecific product performance anomaly. Subsequently, this device was explanted and replaced. This product has not been returned for analysis. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893447 ↗MalfunctionSep 24, 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. Continued monitoring until radio frequency (RF) telemetry disabled was recommended. The device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884199 ↗MalfunctionSep 24, 2026Nonstandard Device
It was reported that this pacemaker was returned with no reported product performance issues or adverse patient effects. Analysis completed in our Post Market Quality Assurance laboratory identified a product performance issue. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876651 ↗MalfunctionSep 23, 2026Over-Sensing
It was reported that this pacemaker had a history of exhibiting crosstalk. Technical Services (TS) reviewed device data and recommended programming changes. The health care professional (HCP) indicated that the patient would be further evaluated. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871814 ↗MalfunctionSep 18, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831065 ↗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. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819781 ↗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. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813074 ↗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. 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 50805832 ↗MalfunctionSep 17, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804000 ↗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. 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 50790272 ↗MalfunctionSep 15, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775863 ↗InjurySep 15, 2026Insufficient Device Problem Information
It was reported that this device was explanted due to an unknown product anomaly. 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 50771531 ↗MalfunctionSep 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. No adverse patient effects were reported. This device remains in service at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736654 ↗MalfunctionSep 9, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703211 ↗InjurySep 9, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702252 ↗MalfunctionSep 9, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697630 ↗
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
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 reports
- ESSENTIO™ MRI DR L111Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls9 deaths1,790 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.