Maximo® II VR D284VRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00613994446619), received between Feb 9, 2017 and Jul 29, 2025 — classified as 2 deaths, 60 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (17 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 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT DURING USE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED END OF SERVICE (EOS) AND PHYSICIAN DECIDED NOT TO CHANGE OUT OR REMOVE THE DEVICE.  ADDITIONALLY, A REQUEST WAS MADE FOR ACTIONS TO TAKE IF THE ICD IS NOT TONING FOR CHARGE CIRCUIT TIMEOUT.  IT WAS EXPLAINED THAT SHOULD ICD CHANGE OUT NOT OCCUR,  THE CHARGE CIRCUIT TIMEOUT IS A NON-PROGRAMMABLE ALERT AND CAN OCCUR AGAIN.  THE ICD REMAINS IN USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642971 ↗
• InjuryJul 15, 2025Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ALERTS FOR CHARGE CIRCUIT TIMEOUT AND CHARGE TIME OF OVER THIRTY SECONDS. RECOMMENDED REPLACEMENT TIME (RRT) HAD BEEN REACHED APPROXIMATELY THREE YEARS PRIOR. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512052 ↗
• MalfunctionJul 3, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THAT WAS PREVIOUSLY PROGRAMMED OFF AND IS NOW AT END OF SERVICE (EOS), EXHIBITED A CHARGE CIRCUIT TIMEOUT. THE DEVICE REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394864 ↗
• MalfunctionOct 31, 2024Device Alarm System; Premature Discharge of Battery; Communication or Transmission Problem; Device Alarm System; Premature Discharge of Battery; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ESTABLISH TELEMETRY AND UNEXPECTED BATTERY DEPLETION WAS SUSPECTED. A MAGNET WAS PLACED OVER THE DEVICE; HOWEVER, NO ALERT TONE WAS HEARD. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577765 ↗
• MalfunctionJun 17, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED WITH A PROGRAMMER. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554466 ↗
• MalfunctionJun 10, 2024Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) 16 MONTHS PRIOR. THE ICD WAS NOW AT END OF SERVICE (EOS) AND ALERTS WERE TRIGGERED FOR CHARGE CIRCUIT TIMEOUT (CCT) AND FOR LONG CHARGE TIME OF 30 SECONDS.  THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500006 ↗
• InjuryApr 9, 2024Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR HIGH AND UNDEFINED HIGH RV DEFIBRILLATION COIL IMPEDANCE VALUES. IN ADDITION, THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND A HIGH SENSING INTEGRITY COUNTER (SIC) VALUE. THE LEAD ALSO TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH RV PACING IMPEDANCE VALUE. THE DEVICE REACHED END OF SERVICE (EOS) AND TRIGGERED ALERTS FOR LONGER THAN EXPECTED CHARGE TIME AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND CHARGE CIRCUIT TIMEOUT. ADDITIONALLY, THE DEVICE EXHIBITED CHARGE CIRCUIT INACTIVE. THE DEVICE WAS EXPLANTED AND THE LEAD IS NO LONGER IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071024 ↗
• MalfunctionApr 24, 2023Failure to Charge; Electrical /Electronic Property Problem; Battery Problem; Failure to Charge; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS AT END OF SERVICE (EOS) AND INTERROGATED A CHARGE CIRCUIT T IMEOUT/INACTIVE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16798986 ↗
• MalfunctionDec 5, 2022Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALERTING FOR CHARGE CIRCUIT TIMEOUT/CHARGE CIRCUIT INACTIVE. IT WAS NOTED THAT THE ICD WAS THREE YEARS POST END OF SERVICE (EOS) STATUS. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915148 ↗
• MalfunctionNov 7, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED BY THE PATIENT THAT THEIR REMOTE MONITOR COULD NOT ESTABLISH TELEMETRY WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). TROUBLESHOOTING WAS PERFORMED, HOWEVER TELEMETRY WAS UNABLE TO BE ESTABLISHED. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743065 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. THE DEVICE WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15410282 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14316677 ↗
• InjuryApr 5, 2022Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) FOR CHEST PAIN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) AND HAD A CHARGE CIRCUIT TIMEOUT. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 14018422 ↗
• MalfunctionMar 31, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE DEVICE HAS BEEN END OF SERVICE (EOS) SINCE 2019. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966963 ↗
• InjuryDec 22, 2021Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED WITH THE PROGRAMMER. THE ICD WAS REMOVED DUE TO NORMAL BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059796 ↗
• MalfunctionNov 12, 2021Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT INTO END OF SERVICE (EOS) IN 2017 AND THE PATIENT ELECTED NOT TO REPLACED THE DEVICE. RECENTLY A CHARGE CIRCUIT TIMEOUT OCCURRED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804126 ↗
• InjuryAug 30, 2021Premature Discharge of Battery; Failure to Charge; Delayed Charge Time; Premature Discharge of Battery; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED END OF SERVICE (EOS) PREMATURELY. THE ICD EXHIBITED PROLONGED CHARGE TIME, AND A CHARGE CIRCUIT TIMEOUT OCCURRED. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384912 ↗
• MalfunctionJul 19, 2021Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS FURTHER REPORTED THAT THE ICD TRIGGERED AN ALERT FOR A CHARGE CIRCUIT INACTIVE. THE ALERT WAS CLEARED, AND THE DEVICE REMAINS IMPLANTED WITH ALL PROGRAMMABLE ALERTS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188730 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A REPRESENTATIVE OF THE PATIENT THAT AN AUDIBLE ALERT HAD BEEN EMITTING FROM THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR THE PAST FOUR WEEKS. THE PATIENT HAS BEEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND IT WAS INDICATED THE DEVICE WAS "FAILING". THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12108638 ↗
• InjuryMay 20, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT FELT PAIN AROUND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT SITE AND INDICATED THAT THE ICD MAY HAVE MIGRATED. IT WAS NOTED THAT THE ICD WAS AT END OF SERVICE (EOS). THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 11856565 ↗
• MalfunctionApr 6, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT). APPROXIMATELY SIX MONTHS LATER, THE DEVICE TRIGGERED CHARGE CIRCUIT INACTIVE FOLLOWING APPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY WHICH WAS MONTHS AFTER THE DEVICE WAS THOUGHT TO HAVE REACHED END OF SERVICE (EOS). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618847 ↗
• InjuryMar 15, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS FAST VENTRICULAR TACHYCARDIA (VT). THE ICD WAS EXPLANTED, AND THE PATIENT WAS UPGRADED TO A DUAL CHAMBER ICD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11485632 ↗
• InjuryFeb 23, 2021Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED AN ELECTRICAL RESET. THE DEVICE WAS INTERROGATED, EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365087 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10800800 ↗
• MalfunctionSep 29, 2020Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) DUE TO EXCESSIVE CHARGE TIME. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10600294 ↗