ACCOLADE™ SR L300Recalls & reported problems

Summary

The FDA's MAUDE database contains 574 adverse event reports that list this exact device (DI 00802526559150), received between Apr 21, 2016 and Sep 29, 2026 — classified as 5 deaths, 366 injuries, 203 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (246 reports).

1 FDA recall record name this device's identifier, 1 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-0092-2026 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 574 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938359 ↗
• MalfunctionSep 24, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883760 ↗
• MalfunctionSep 15, 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. Device replacement was recommended. 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 50773494 ↗
• MalfunctionSep 7, 2026Premature Discharge of Battery; Use of Device Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656733 ↗
• 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. 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 50602454 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602449 ↗
• MalfunctionSep 2, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569228 ↗
• MalfunctionAug 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. The pacemaker will remain implanted and the patient will be monitored until radio frequency (RF) telemetry disablement, at which time device replacement should be scheduled. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311728 ↗
• MalfunctionJun 29, 2026Signal Artifact/Noise; Nonstandard Device; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A SIGNAL ARTIFACT MONITORING (SAM) EPISODE DUE TO NOISE ARTIFACT OF THE MINUTE VENTILATION (MV) FEATURE SIGNAL. WHICH WAS CAUSED BY ELECTROMAGNETIC INTERFERENCE (EMI). LEADING TO THE MINUTE VENTILATION (MV) FEATURE BEING AUTOMATICALLY DISABLED. ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. NO PROGRAMMING CHANGES WERE RECOMMENDED. AT THIS TIME, THE PACEMAKER REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659560 ↗
• MalfunctionMay 26, 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 25280098 ↗
• MalfunctionMay 7, 2026Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DROPPED ITS LONGEVITY FOR ONE YEAR IN JUST SIX MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THIS COULD BE DUE TO ROUNDING UP FROM 2.5 TO 3 YEARS AT LAST CHECK OR ROUNDING DOWN FROM 2.5 TO 2 AT THIS CHECK. TS CONFIRMED DEVICE POWER COMPARISON WAS AT 100 PERCENT. ALSO, DEVICE WAS AT ATRIAL ANTI-BRADYCARDIA PACING AND PACING AT 21 PERCENT. TS THEN EXPLAINED THIS SOUNDS UNREASONABLE AND ADVISED TO SEND IN DATA FOR ANALYSIS. ADDITIONAL INFORMATION INDICATED THAT NO FURTHER ACTION WAS TAKEN AND THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS SATISFIED WITH THE BATTERY ROUNDING EXPLANATION. ALSO, DEVICE WAS INTERROGATED, AND THE RECENT BATTERY CALCULATION WAS 2.5 YEARS WHICH IS COMPLETELY REASONABLE. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116563 ↗
• MalfunctionMay 4, 2026Signal Artifact/Noise; Premature Discharge of Battery; High impedance; Over-Sensing

  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 25073473 ↗
• InjuryApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER HAD REVERTED TO SAFETY MODE. THIS PACEMAKER WAS SUBSEQUENTLY EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983070 ↗
• InjuryApr 16, 2026Premature Discharge of Battery; Nonstandard Device

  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. THIS DEVICE WAS EXPLANTED AND HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897238 ↗
• InjuryMar 31, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED. TECHNICAL SERVICES (TS) NOTED BASED ON THE AGE OF THE DEVICE, IT MAY NO LONGER BE FUNCTIONAL. TS ALSO RECOMMENDED TRYING TO PLACE A MAGNET. IT WAS NOTED THE PATIENT PRESENTED TO THE PHYSICIAN TO DISCUSS DEVICE REPLACEMENT. THIS PACEMAKER REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT 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 24745171 ↗
• InjuryMar 25, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. DATA ANALYSIS IDENTIFIED A POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. AS A RESULT, DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687809 ↗
• InjuryMar 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 24597778 ↗
• MalfunctionMar 6, 2026High impedance; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS PACEMAKER DISPLAYED A RED CALL DOCTOR ALERT. ADDITIONALLY, IT WAS FOUND THAT THIS DEVICE AND THE COMMUNICATOR FOR THE PATIENT COULD NOT ESTABLISH A CONNECTION. AT THIS TIME, THE REASON FOR THE ALERT REMAINS UNKNOWN. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED STATING THIS PACEMAKER SYSTEM EXHIBITED A LEAD SAFETY SWITCH (LSS) DUE TO PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD IS NOT A BOSTON SCIENTIFIC PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533658 ↗
• InjuryFeb 18, 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. 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 24381407 ↗
• InjuryJan 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. DATA ANALYSIS IDENTIFIED A POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. AS A RESULT, DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020358 ↗
• InjuryNov 26, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR 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 AS THE BATTERY IMPEDANCE IS EXPECTED TO INCREASE, AND RADIO FREQUENCY (RF) TELEMETRY WILL EVENTUALLY BE DISABLED. THIS DEVICE REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS PACEMAKER WAS SUBSEQUENTLY EXPLANTED AND SUCCESSFULLY REPLACED. OTHER THAN THE INTERVENTION NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662216 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23647198 ↗
• InjuryNov 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS SCHEDULED FOR A POCKET REVISION FOR AN UNSPECIFIED REASON. IT WAS NOTED THAT 1.5 YEARS REMAINED ON THE BATTERY FOR THIS PACER DEPENDENT PATIENT, AND IT WAS NOTED THAT THIS DEVICE DID NOT HAVE THE RECENT SOFTWARE UPDATE. ADDITIONAL INFORMATION RECEIVED THE POCKET WAS NOT REVISE, BUT THE PACEMAKER WAS EXPLANTED AND REPLACED INSTEAD, DUE TO ADVISORY CONCERNS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592846 ↗
• InjuryOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS IMPLANTABLE PACEMAKER ENTERED IN SAFETY MODE. NO OTHER INFORMATION WAS PROVIDED. AFTER SAFETY MODE OCCURRED THIS DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352280 ↗
• InjuryOct 21, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER 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 WAS EXPLANTED AND WAS NOT RETURNED FOR ANALYSIS. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349681 ↗