FORTIFY™ CD1231-40QRecalls & reported problems

Summary

The FDA's MAUDE database contains 618 adverse event reports that list this exact device (DI 05414734504348), received between Jun 11, 2018 and Sep 17, 2026 — classified as 3 deaths, 523 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (281 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 618 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Premature Discharge of Battery; Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812237 ↗
• InjuryMar 9, 2026Premature Discharge of Battery; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACKUP VVI MODE DUE TO PREMATURE BATTERY DEPLETION, RESULTING IN A LOSS OF HIGH VOLTAGE THERAPIES. THE ICD WAS EXPLANTED AND SUCCESSFULLY REPLACED, AND THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551518 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH REDNESS, DISCHARGE AND INFECTION AT DEVICE POCKET. THE WOUND HAS NOT HEALED PROPERLY. THE INFECTION WAS NOT ASSOCIATED WITH ANY ABBOTT PRODUCT AND/OR PROCEDURE. THE HIGH VOLTAGE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 24000309 ↗
• InjuryNov 26, 2025Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A DEVICE INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACKUP VVI MODE. THE ICD WAS RESTORED TO NORMAL FUNCTION. IT WAS ALSO NOTED THAT THE ICD DELIVERED MULTITUDE OF INAPPROPRIATE SHOCKS WITH THE BATTERY INDICATING LESS THAN 3 MONTHS TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND IN STABLE CONDITION. THE ICD REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660585 ↗
• InjuryMar 11, 2025Premature Discharge of Battery; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN CLINIC FOLLOW UP. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP VVI MODE. THE DEVICE'S BATTERY HAD PREMATURELY DEPLETED AFTER PROVIDING CONSTANT APPROPRIATE SHOCK THERAPY. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573843 ↗
• InjurySep 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO AN INFECTION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN DOES NOT ALLEGE ABBOTT DEVICES OR ANY PROCEDURE INVOLVING THE ABBOTT DEVICES, CAUSED, OR CONTRIBUTED TO THE INFECTION. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD AND RV LEAD. THE PATIENT WAS RECOVERING AFTER THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 20166418 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2024-60603. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POCKET INFECTION APPROXIMATELY ONE MONTH POST INITIAL IMPLANT PROCEDURE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, INCLUDING THE RIGHT VENTRICULAR (RV) LEAD. IT WAS SUSPECTED TO BE DEVICE RELATED. THE SYSTEM WAS EXPLANTED. PATIENT CONDITION WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 19785678 ↗
• InjuryJul 11, 2024Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT VIA VOLUNTARY MEDWATCH THAT THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCK FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO INCORRECT INTERPRETATION OF SIGNALS. PROGRAMMING CHANGES WERE MADE; HOWEVER, THE ICD RE-EXHIBITED INAPPROPRIATE SHOCKS. PATIENT HAD CLAIMED TO HAVE SUSTAINED NERVE AND MUSCLE DAMAGE AS WELL AS SUFFERED FROM POST-TRAUMATIC STRESS DISORDER DUE TO THE "OVER-POWER" INAPPROPRIATE SHOCKS. EFFORTS TO DEACTIVATE THE DEVICE WERE MADE. INFORMATION REGARDING PATIENT OUTCOME AND FURTHER INTERVENTION WAS NOT PROVIDED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Discomfort

  MAUDE report 19727210 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR EXCHANGE WITH DISCOMFORT OF AT THE POCKET SITE. THE POCKET WAS REVISED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 19335150 ↗
• InjuryMay 3, 2024Failure to Convert Rhythm; Inappropriate or Unexpected Reset; Failure to Convert Rhythm; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO RECEIVING SEVERAL APPROPRIATE SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT FAILED TO CONVERT THE PATIENT'S ARRHYTHMIA. THE ARRYTHMIA WAS CONVERTED VIA ADMINISTERING MEDICATION. ADDITIONALLY, IT WAS NOTED THAT THE ICD INAPPROPRIATELY SWITCHED TO BACKUP (BVVI) MODE DUE TO A HARDWARE RESET WHICH RESULTED IN LOSS OF DEFIBRILLATION THERAPY. THE ICD WAS REPROGRAMMED SUCCESSFULLY, AND THE PATIENT LEFT IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 19238266 ↗
• MalfunctionFeb 21, 2024Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE WITH NO HV THERAPIES ACTIVE DUE TO OFF-LABEL MRI ENVIRONMENT. THE ICD WAS RESTORED BACK TO NORMAL SETTINGS. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754743 ↗
• MalfunctionFeb 14, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT AFTER UNPACKING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR A NEW IMPLANT PROCEDURE, IT WAS NOTED THAT THE WIRELESS TELEMETRY SIGNAL WAS VERY UNSTABLE AND ONLY SHOWED THREE BARS, BUT THE PROGRAM INTERFACE HAD NO ACTUAL DATA EVEN AT A CLOSE DISTANCE. SEVERAL ATTEMPTS WERE MADE TO INTERROGATE THE ICD BUT FAILED. THE PHYSICIAN WAS CONCERNED THERE MAY BE A PROBLEM WITH THE ICD PROGRAM CONTROL MODULE. THE ICD WAS EXCHANGED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708325 ↗
• InjuryFeb 6, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT FROM (B)(6) 2023 THE BATTERY VOLTAGE WAS AT 1.4 YEARS AND THEN HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) IN JUN 2023. A SUDDEN ERI WAS NOTED. THE DEVICE WAS EXPLANTED. THE PATIENT WAS FINE WITH NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651028 ↗
• InjuryNov 28, 2023Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221690 ↗
• InjuryNov 27, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED, THAT THERE WAS ANOMALY ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213562 ↗
• InjuryOct 26, 2023Failure to Convert Rhythm; Inappropriate or Unexpected Reset; Failure to Convert Rhythm; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN HOSPITAL WITH SUSTAINED VENTRICULAR TACHYCARDIA. IT WAS BELIEVED BY THE PHYSICIAN THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INADEQUATE HIGH VOLTAGE THERAPY. EXTERNAL DEFIBRILLATION WAS PERFORMED TO CONVERT THE RHYTHM. UPON INTERROGATION FOR PROGRAMMING CHANGES, IT WAS FOUND THAT THE ICD HAD GONE INTO BACKUP OPERATION DUE TO UNKNOWN REASON. THE ICD WAS NOT RESTORED, AND MEDICATION TREATMENT WAS PRESCRIBED. PATIENT CONDITION WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 18014188 ↗
• InjurySep 26, 2023Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822481 ↗
• MalfunctionSep 5, 2023Premature Discharge of Battery; Premature Discharge of Battery

  NEW INFORMATION NOTES THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. PATIENT CONDITION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17687671 ↗
• InjuryAug 31, 2023Tactile Prompts/Feedback; Tactile Prompts/Feedback

  IT WAS REPORTED, THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND, THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOTIFIER ANOMALY, DUE TO WHICH THE ICD WAS VIBRATING EVERY FOR MINUTES. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 17666915 ↗
• MalfunctionAug 16, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC FOR A GENERATOR EXCHANGE PROCEDURE. IT WAS NOTED THAT THE PATIENT REQUESTED THE POCKET CONTAINING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BE REVISED DUE TO PERCEIVED UNCOMFORTABLE INTERACTIONS WITH THEIR SHOULDER. THE ICD WAS EXPLANTED AND REPLACED, AND THE POCKET WAS REVISED SUCCESSFULLY. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557402 ↗
• InjuryAug 11, 2023Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED, THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INAPPROPRIATE SHOCK, DUE TO NOISE OVERSENSING. NO INTERVENTION WAS DONE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515533 ↗
• MalfunctionAug 2, 2023Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 17440396 ↗
• MalfunctionJul 28, 2023Environmental 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 MODE FOLLOWING USE OF MAGNETIC RESONANCE IMAGING (MRI). DEVICE MRI PROCEDURE WAS NOT PERFORMED PRIOR TO THE SCAN, AND THIS CAUSED THE DEVICE TO RESET AND LOSE DEFIBRILLATION ABILITY. THE DEVICE WAS ABLE TO BE SUCCESSFULLY RESTORED BACK TO NORMAL FUNCTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420669 ↗
• MalfunctionJun 20, 2023Inappropriate or Unexpected Reset; Compatibility Problem; Inappropriate or Unexpected Reset; Compatibility Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AFTER MRI. INTERROGATION NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP MODE. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166230 ↗
• MalfunctionJun 2, 2023Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 17054623 ↗