PROPONENT™ DR L201Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00802526559044), received between Apr 16, 2019 and Jan 27, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (7 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.

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-0086-2026 · Root cause: Other · 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-0823-2025 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER EXPERIENCED A SYNCOPAL EVENT. WHEN THE DEVICE WAS CHECKED, A RED WARNING SCREEN WAS DISPLAYED ON THE PROGRAMMER, INDICATING THE DEVICE HAD REVERTED TO SAFETY MODE OPERATION. THE DEVICE HAD ONLY BEEN IMPLANTED FOR ABOUT FOUR YEARS; PREMATURE BATTERY DEPLETION WAS SUSPECTED, AND THE DEVICE WAS NOT ABLE TO BE REPROGRAMMED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PAUSES IN PACING WERE OBSERVED ON THE ELECTROCARDIOGRAM. THE DEVICE WAS EXPLANTED AND REPLACED THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Syncope/Fainting

  MAUDE report 16253486 ↗
• MalfunctionDec 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE PREMATURELY DEPLETING. IT WAS ALSO REPORTED THAT THE PATIENT'S ASSOCIATED LEAD WAS NOT WORKING, HOWEVER WE HAVE NO INFORMATION ON THE MODEL AND/OR SERIAL COMBINATION OF THIS PRODUCT. AT THIS TIME, NO INTERVENTION HAS BEEN PERFORMED AND THE PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977618 ↗
• MalfunctionNov 8, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A FOLLOW UP THERE WAS EVIDENCE OF A CHANGE IN THE BATTERY LIFE OF APPROXIMATELY TWO YEARS SINCE THE LAST FOLLOW UP WHICH WAS SIX MONTHS AGO. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752960 ↗
• MalfunctionJul 3, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY, AS NOTED DURING A ROUTINE FOLLOW-UP. SIX MONTHS PRIOR, THE BATTERY WAS AT 5.5 YEARS OF REMAINING LIFE HOWEVER, AT THE MOST RECENT CHECK UP, THE REMAINING LIFE HAD DROPPED TO THREE YEARS. THE PHYSICIAN STATED NO INTERVENTION AT THIS TIME AND PLANS TO MONITOR EVERY SIX MONTHS. NO RESULTING ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114079 ↗
• MalfunctionJan 26, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER DEVICE IS BEHAVING IN A MANNER CONSISTENT WITH A PREMATURE BATTERY DEPLETION (PBD). THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11232899 ↗
• InjuryJan 26, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. THIS DEVICE WAS REPLACED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11228629 ↗
• InjuryApr 24, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE WAS EXHIBITING BEHAVIOR CONSISTENT WITH PREMATURE BATTERY DEPLETION (PBD) . THE DEVICE WAS EXPLANTED, AND A NEW DEVICE IMPLANTED. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED.

  Patient problems: No Code Available

  MAUDE report 9995430 ↗
• MalfunctionJan 15, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS DEVICE DECLARED A CODE 1003 PRIOR TO IMPLANT. SUBSEQUENTLY, THE PHYSICIAN CHOSE TO USE A DIFFERENT DEVICE. THERE WAS NO PATIENT INVOLVEMENT. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9593508 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8519225 ↗