Current Accel® DR (REF CD2215-36Q)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734503075), received between Jul 16, 2018 and Oct 6, 2021 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (3 reports).

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.

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.

• MalfunctionOct 6, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT UPON INTERROGATION, BACKUP VVI ISSUE WAS OBSERVED ON THE DEVICE. THE CLINIC INFORMED THE PATIENT. THE PATIENT¿S CONDITION WAS STABLE AND BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583565 ↗
• InjuryJan 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED AN UNKNOWN MALFUNCTION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11108505 ↗
• InjuryNov 13, 2019Premature Discharge of Battery; Premature Discharge of Battery

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS NOTED TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE PHYSICIAN ALLEGES PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9315373 ↗
• InjurySep 16, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION. THERE WERE NO CONSEQUENCES TO THE PATIENT. NO INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9070936 ↗
• InjuryNov 5, 2018Premature Discharge of Battery; Premature Discharge of Battery

  DURING A CLINIC FOLLOW UP, IT WAS NOTED THAT THE DEVICE HAD AN ALERT FOR ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8040035 ↗
• MalfunctionOct 5, 2018Over-Sensing; Over-Sensing

  DURING FOLLOW-UP, AUTOMATIC MODE SWITCHING (AMS) DUE TO OVERSENSING WAS NOTED. REPROGRAMING WAS PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION. MANUFACTURER REPORT NUMBER: 2017865-2018-14758.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7938029 ↗
• MalfunctionAug 21, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT INAPPROPRIATE AUTO-MODE SWITCH EPISODES DUE TO FAR R-WAVE OVERSENSING WERE OBSERVED. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7803611 ↗
• InjuryJul 27, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER RECEIVING HIGH VOLTAGE THERAPY. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED BACKUP VVI OPERATION. IT IS UNKNOWN IF THE THERAPY WAS APPROPRIATE. NO SOURCES OF ELECTROMAGNETIC INTERFERENCE WERE NOTED. A DEVICE DOWNLOAD WAS UNABLE TO BE PERFORMED DUE TO AN UNEXPLAINED POWER ON RESET. ON (B)(6) 2018 THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7726778 ↗
• MalfunctionJul 16, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REACHED NORMAL END OF SERVICE ON (B)(6) 2018. UPON REVIEW, THE DEVICE EXHIBITED BVVI ON AN UNKNOWN DATE. NO INTERVENTION WAS REPORTED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7691334 ↗