ACCOLADE™ DR L301Recalls & reported problems
Boston Scientific Corporation · Pacemaker · Class 3 · Implant
Data updated Oct 13, 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 Accolade DR pacemaker has 2,496 adverse event reports, including 6 deaths and 1,549 injuries. Many reports describe batteries running down early, the pacemaker misreading heartbeats, and high electrical resistance, and some led to device replacement. Two recalls are open, both over high battery resistance that can trigger a backup mode, with a software update available for one.
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
- 2,513
- Deaths reported
- 6
- Injuries reported
- 1,547
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2,513 adverse event reports that list this exact device (DI 00802526559174), received between Apr 21, 2016 and Sep 30, 2026 — classified as 6 deaths, 1,547 injuries, 960 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (774 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-0093-2026 · 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 Battery774
- Over-Sensing400
- High impedance382
- Defective Device362
- Adverse Event Without Identified Device or Use Problem304
- Incorrect, Inadequate or Imprecise Result or Readings272
- Pacing Problem231
- Battery Problem211
Patient problems
- No Clinical Signs, Symptoms or Conditions1,181
- No Known Impact Or Consequence To Patient553
- Unspecified Infection255
- No Code Available154
- No Consequences Or Impact To Patient149
- Insufficient Information100
- Sepsis82
- Syncope74
Recent adverse event reports
The 25 most recent of 2,513 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. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947943 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937594 ↗MalfunctionSep 25, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892573 ↗MalfunctionSep 17, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810287 ↗MalfunctionSep 16, 2026Signal Artifact/Noise; Failure to Capture; Pacing Problem; High Capture Threshold
Patient problems: Bradycardia
MAUDE report 50796835 ↗MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794893 ↗MalfunctionSep 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. 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 50649891 ↗InjurySep 4, 2026Premature Discharge of Battery
It was reported that this device recorded a Code 1003, which states that the voltage is too low for projected remaining capacity. The device was subsequently explanted. A new device was implanted. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614137 ↗MalfunctionSep 4, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50602328 ↗MalfunctionAug 19, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329742 ↗MalfunctionAug 18, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50295718 ↗InjuryAug 17, 2026Pacing Problem; Interrogation Problem
It was reported that during a device check, this pacemaker was found to have low battery which prevented device interrogation. It was noted the device was implanted over ten years ago. The patient had a pulse of 32 beats per minute (BPM) and the patient was referred to the emergency department for evaluation and 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: Bradycardia; Syncope/Fainting
MAUDE report 50284703 ↗InjuryAug 17, 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. The patient underwent a surgical intervention to explant this device and implant a new pacemaker. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280339 ↗MalfunctionAug 14, 2026Premature Discharge of Battery
It was reported that this device recorded a Code 1003, which states that the voltage is too low for projected remaining capacity. It was reported that 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. 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 50261950 ↗MalfunctionAug 12, 2026Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217665 ↗InjuryAug 11, 2026Pacing Problem; Data Problem; Interrogation Problem
It was reported that programmer interrogation of this pacemaker was unsuccessful, and multiple programmer wands were attempted. Additionally, there was no magnet response, and four different magnets were attempted. There was no change in pacing even with magnet stacked, and the intrinsic rate was in the 50s beats per minute (BPM) range. It was noted that the pacemaker was implanted more than 10 years ago, and it was likely the battery had reached End of Life (EOL). Additional information received reported that this pacemaker was likely explanted and replaced with a non Boston Scientific device. No additional adverse patient effects were reported. Product return was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216514 ↗InjuryAug 11, 2026Premature Discharge of Battery; Use of Device Problem; Interrogation Problem
It was reported that this pacemaker recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. Additionally remote monitoring was disabled. This device was explanted and replaced. No additional adverse patient effects were reported. This device has not been returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213575 ↗MalfunctionAug 11, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209657 ↗MalfunctionAug 11, 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. 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 50201393 ↗InjuryAug 4, 2026Extracardiac stimulation; Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the patient presented to the emergency room (ER) due to feeling intermittent pocket stimulation, with a heart rate in the 70's. A magnet was applied to the pacemaker and no response was elicited. After discussion with Technical Services, and performing a device interrogation, it was determined that the device was in Safety Mode. The device was immediately replaced and received for analysis.
Patient problems: Device Overstimulation of Tissue
MAUDE report 50129049 ↗MalfunctionJul 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086005 ↗MalfunctionJul 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. 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 50083540 ↗MalfunctionJul 27, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038619 ↗MalfunctionJul 27, 2026Interrogation Problem
It was reported that the communicator of this pacemaker displayed a yellow collecting wave. The patient removed their Apple Watch and power cycled the communicator, a patient-initiated interrogation (PII) was allowed; however, the yellow collecting wave still appeared. Analysis revealed the device and communicator were unable to communicate with one another. Technical Services (TS) referred the patient to the clinic to discuss possible radio frequency (RF) settings. No adverse patient effects were reported. This pacemaker remains in service.Additional information was received and it was reported that this pacemaker was explanted and successfully replaced with a non-Boston Scientific device. 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 50036635 ↗MalfunctionJul 27, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015558 ↗
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™ 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
- ESSENTIO™ MRI DR L111Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls9 deaths1,790 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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