Current Accel™ VR (REF CD1215-36Q)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734503044), received between Jun 25, 2018 and Dec 28, 2022 — classified as 1 death, 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2022 WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AT LESS THAN THREE MONTHS FROM ELECTIVE REPLACEMENT INDICATOR (ERI). A PREVIOUS INTERROGATION ON (B)(6) 2020 HAD DISPLAYED A BATTERY LONGEVITY OF THREE YEARS, SO PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE ICD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064427 ↗
• MalfunctionOct 2, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST SENSED T-WAVE OVER-SENSING (PSTWOS) DURING EPISODES OF SUPRAVENTRICULAR TACHYCARDIA (SVT). NO INTERVENTION WAS PERFORMED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566461 ↗
• MalfunctionAug 19, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE DEVICE WAS EXHIBITING UNDERSENSING OF VENTRICULAR EVENTS. THE PATIENT PRESENTED TO THE CLINIC AND PROGRAMMING CHANGES WERE MADE. THERE WERE NO HEALTH ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10425994 ↗
• MalfunctionJun 26, 2020Under-Sensing; Under-Sensing

  PRIOR TO ELECTIVE REPLACEMENT PROCEDURE, EPISODES OF UNDERSENSING WERE NOTED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED DEVICE REPROGRAMMING. THE DEVICE EXPLANTED AND REPLACED, THE REPLACEMENT DEVICE WAS REPROGRAMMED TO TECHNICAL SUPPORTS RECOMMENDATIONS TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10201293 ↗
• MalfunctionNov 27, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INACCURATE BATTERY LONGEVITY WAS OBSERVED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9387246 ↗
• InjuryNov 18, 2019Incorrect Measurement; Incorrect Measurement

  NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9338735 ↗
• MalfunctionNov 4, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE CLINIC FOLLOW-UP. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED BATTERY LONGEVITY ANOMALY WITH A CHARGE TIME OF 15.3 SECONDS. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9273758 ↗
• InjuryFeb 5, 2019Failure to Charge; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Failure to Charge; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO ATRIAL FIBRILLATION. ON (B)(6) 2019 THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS INTERROGATED. UPON REVIEW, THE PATIENT'S DEVICE EXHIBITED A CHARGE TIME-OUT ALERT. THE PATIENT WAS STABLE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8305197 ↗
• MalfunctionJan 16, 2019Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  DURING FOLLOW-UP, POST SENSED T-WAVE OVERSENSING (PSTWOS) WAS OBSERVED ON THE DEVICE. THE ISSUE WAS RESOLVED BY REPROGRAMMING THE DEVICE BUT RESULTED IN UNDERSENSING. TECHNICAL SUPPORT WAS CONTACTED AND SUGGESTED TO KEEP THE NEW PROGRAMMED SETTINGS TO AVOID THE PSTWOS. FURTHER INFORMATION WAS REQUESTED BUT NOT YET AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253144 ↗
• DeathNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death

  MAUDE report 8108751 ↗
• MalfunctionNov 21, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH A DEVICE THAT EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8095288 ↗
• InjuryJun 25, 2018Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time

  THE DEVICE WAS INTERROGATED AND THE CAPACITOR CHARGE TIME LIMIT WAS REACHED. HOWEVER, SINCE THE PATIENT RECEIVED SEVERAL SHOCKS AND THE BATTERY VOLTAGE WAS DECREASED, THE EXTENDED CHARGE TIME WAS NOTED TO BE NORMAL. SEVERAL VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) EPISODES WERE OBSERVED WHICH WERE CAUSED BY ATRIAL FIBRILLATION WITH HIGH VENTRICULAR FREQUENCY RESULTING IN INAPPROPRIATE SHOCKS. IN OTHER CASES, REAL VT EPISODES WERE RECORDED AND TREATED APPROPRIATELY. THE VF ZONE WAS INCREASED AND NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT IS HOSPITALIZED FOR OTHER COMORBIDITIES. THE DEVICE WAS IMPLANTED IN 2013; HOWEVER, THE EXACT DATE IS UNKNOWN.

  Patient problems: Atrial Fibrillation; Therapeutic Effects, Unexpected

  MAUDE report 7633925 ↗