FORTIFY™ CD2231-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 334 adverse event reports that list this exact device (DI 05414734504379), received between Jun 11, 2018 and Jun 15, 2026 — classified as 4 deaths, 226 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (81 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 334 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511006 ↗
• InjuryApr 28, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL EXPERIENCING DISCOMFORT. UPON REVIEW, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCORRECT INTERPRETATION OF SIGNAL RESULTING IN THE DELIVERY OF INAPPROPRIATE SHOCKS. THE ICD AND RV LEAD WAS REPROGRAMMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 25017572 ↗
• MalfunctionApr 6, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795329 ↗
• InjuryMar 17, 2026Premature Discharge of Battery; Failure to Charge; Failure to Convert Rhythm; Inappropriate or Unexpected Reset

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE PATIENT HAD EXPERIENCED VENTRICULAR TACHYCARDIA (VT) BUT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAILED TO PROVIDE EFFECTIVE TREATMENT. IT WAS DISCOVERED THAT THE DEVICE WAS IN BACKUP MODE. DATA ANALYSIS REVEALED THAT THE DEVICE HAD MULTIPLE FAILED CHARGING ATTEMPTS. IT WAS SPECULATED THAT THE CAPACITOR OVERLOAD CAUSED THE ICD TO BE UNABLE TO COMPLETE THE CHARGING PROCESS, AND MULTIPLE CHARGING ATTEMPTS LED TO BATTERY DEPLETION. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 24622059 ↗
• MalfunctionDec 29, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED DUE TO THE PATIENT UNDERGOING A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. THE ICD WAS NOT MRI COMPATIBLE AND WAS NOT PUT INTO MRI MODE PRIOR TO PROCEDURE. PROGRAMMING CHANGES WERE MADE TO RESET THE DEVICE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917111 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. IT WAS NOTED LESS THAN A MONTH AFTER IMPLANT AT A FOLLOW UP VISIT THAT AN ABSCESS WAS PRESENT IN THE WOUND. THE WOUND WAS RED, SWOLLEN BUT NOT OPEN. THE CLINICIAN EXPLANTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD. A RE-IMPLANT WAS TO BE PERFORMED ON THE OPPOSING SIDE AT A LATER DATE. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 23752364 ↗
• MalfunctionDec 2, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI), THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE (BVVI) RESULTING IN HIGH-VOLTAGE (HV) THERAPY BEING DISABLED. THE DEVICE HAD NOT BEEN PROGRAMMED INTO MRI MODE AND IS NOT MRI COMPATIBLE. TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692824 ↗
• MalfunctionOct 17, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED TWICE FOR FOLLOW UP WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN BACKUP OPERATION DUE TO ELECTROMAGNETIC INTERFERENCE. THE PATIENT EXPERIENCED PALPITATIONS AND HIGH VOLTAGE THERAPY WAS DISABLED IN BACKUP. THE DEVICE WAS SUCCESSFULLY RESTORED VIA PROGRAMMING. THE PATIENT WAS RECOVERING AND WAS CAUTIONED TO AVOID THE AREA.

  Patient problems: Discomfort

  MAUDE report 23323137 ↗
• MalfunctionSep 19, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED UNEXPECTED RESET ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101098 ↗
• MalfunctionAug 26, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT'S PRESENTED IN CLINIC FOR FOLLOW UP. A DEVICE INTERROGATION REVEALED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION DUE TO THE PATIENT UNDERGOING A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. IT WAS UNKNOWN IF THE ICD WAS PUT INTO MRI SAFETY MODE PRIOR TO PROCEDURE. IT WAS NOTED THAT HIGH VOLTAGE THERAPIES WERE INACTIVE DURING THE TIME OF RESET. THE DEVICE WAS ABLE TO BE RESTORED TO ITS ORIGINAL SETTINGS THROUGH PROGRAMMING CHANGES. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900887 ↗
• MalfunctionAug 14, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810431 ↗
• InjuryJul 22, 2025Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569556 ↗
• MalfunctionMay 9, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT HAD AN MRI PROCEDURE WITHOUT BEING PROGRAMMED FOR AN MRI CONDITION. THE DEVICE WAS FOUND TO BE IN VVI BACKUP MODE. THE DEVICE WAS RESTORED AND REPROGRAMMED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994753 ↗
• InjuryMay 6, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A FOLLOW-UP CHECK, THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. MULTIPLE ATTEMPTS WERE MADE TO RESTORE THE DEVICE BUT WERE UNSUCCESSFUL. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS GOOD BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968140 ↗
• InjuryMar 25, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692346 ↗
• MalfunctionMar 21, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A HARDWARE RELATED BACKUP MODE WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). HIGH VOLTAGE THERAPIES WERE DISABLED AS A RESULT. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663792 ↗
• InjuryMar 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  RELATED MANUFACTURING REPORT: (B)(4). IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC DUE TO THEIR RIGHT VENTRICULAR (RV) LEAD EXHIBITING HIGH CAPTURE THRESHOLDS. A CHEST X-RAY WAS PERFORMED TO REVEAL THAT THE LEAD HAD BEEN DISLODGED. THE RV LEAD WAS EXPLANTED AND REPLACED. LATER, THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. DEVICE INTERROGATION SHOWED THAT THE ICD EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. PATIENT HAD NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627783 ↗
• InjuryFeb 11, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH TWO INSTANCES OF BACK-UP VVI MODE NOTES ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. BACK-UP DEFIBRILLATION WAS LOST DURING THE EPISODES. THE DEVICE WAS UNABLE TO BE RESTORED, AND EXPLANT OF THE DEVICE WAS DISCUSSED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359409 ↗
• MalfunctionJan 9, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL EXPERIENCING DISCOMFORT. UPON REVIEW, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACK UP MODE. THE ICD WAS SUCCESSFULLY RESTORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 21117809 ↗
• InjuryDec 26, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC AFTER A VIBRATORY ALERT WAS DELIVERED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A DEVICE INTERROGATION REVEALED THAT THE DEVICE HAD ENTERED BACKUP OPERATION. UNSUCCESSFUL ATTEMPTS WERE MADE TO RECOVER THE DEVICE. THE PATIENT WAS SCHEDULED FOR EXPLANT AND THE DEVICE WAS REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023901 ↗
• MalfunctionDec 2, 2024Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD GONE INTO BACKUP VVI MODE AFTER MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED WITHOUT FOLLOWING DEVICE MRI PROTOCOL. HIGH VOLTAGE THERAPY WAS DISABLED. THE DEVICE WAS SUCCESSFULLY REPROGRAMMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819833 ↗
• InjuryNov 20, 2024Break; Inappropriate or Unexpected Reset; Break; Inappropriate or Unexpected Reset

  INFORMATION RECEIVED ON (B)(6) 2024, INDICATES THAT THE OPERATOR THOUGHT THAT THE BACKUP VVI MODE WAS TRIGGERED DUE TO POTENTIAL DEFIBRILLATOR DAMAGE OR QUALITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736636 ↗
• MalfunctionNov 14, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP OPERATION. IT WAS NOTED THAT THE PATIENT FELL AND MAY HAVE CAUSED THE DEVICE TO GO INTO BACKUP MODE. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691753 ↗
• MalfunctionNov 6, 2024Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THE PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC AFTER A MAGNETIC RESONANCE IMAGING (MRI). UPON INTERROGATION, IT WAS DISCOVERED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACK UP MODE WITH NO BACK-UP DEFIBRILLATION OPTION (BDFO) AVAILABLE DUE TO OFF-LABEL USE WITH THE MRI. THE ICD WAS SUCCESSFULLY RESTORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625790 ↗
• InjurySep 27, 2024Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD GONE INTO BACKUP MODE FOLLOWING INAPPROPRIATE SHOCK DUE TO OVERSENSING OF NOISE. THE BACKUP MODE WAS NOTED TO BE CAUSED A POWER ON RESET. THE DEVICE WAS ULTIMATELY DEACTIVATED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319245 ↗