FORTIFY™ CD2231-40QRecalls & reported problems

Summary

The FDA's MAUDE database contains 623 adverse event reports that list this exact device (DI 05414734504386), received between Jun 11, 2018 and Apr 29, 2026 — classified as 15 deaths, 481 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (237 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 623 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD WAS EXPLANTED DUE TO INFECTION. THE PATIENT WAS DISCHARGED WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 25028752 ↗
• InjuryFeb 23, 2026Premature Discharge of Battery; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION DURING DEVICE INTERROGATION. A FOLLOW-UP INTERROGATION REVEALED THAT THE ICD ENTERED BACKUP VVI MODE, WHICH CAUSED THE PATIENT DISCOMFORT DUE TO THE VIBRATION ALERTS. PROGRAMMING CHANGES WERE MADE, AND THE ICD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 24421650 ↗
• InjuryAug 15, 2025Premature Discharge of Battery; Delayed Charge Time; Premature Discharge of Battery; Delayed Charge Time

  NEW INFORMATION RECEIVED INDICATED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN EXPLANTED THE ICD.

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

  MAUDE report 22822219 ↗
• InjuryJul 22, 2025Premature Discharge of Battery; Premature Discharge of Battery

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571212 ↗
• InjuryMay 13, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP MODE AND THAT MULTIPLE SHOCKS WERE SEEN TO BE DELIVERED THE NIGHT BEFORE, BUT THEIR APPROPRIATENESS WAS UNABLE TO BE VERIFIED. IT WAS BELIEVED THAT ELECTROMAGNETIC INTERFERENCE FROM A NEARBY ELECTRICAL SUBSTATION MAY HAVE CONTRIBUTED TO THE DEVICE ENTERING BACKUP MODE. THE DEVICE WAS SUCCESSFULLY RESTORED BACK TO NORMAL FUNCTION. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012053 ↗
• DeathJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19828931 ↗
• MalfunctionApr 25, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON INTERROGATION, IT WAS DISCOVERED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181993 ↗
• MalfunctionMar 15, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IN BACKUP OPERATION. THE PATIENT WAS STABLE. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915173 ↗
• InjuryFeb 17, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAILED TO BE INTERROGATED IN CLINIC. IT COULD NOT BE DETERMINED WHETHER THE DEVICE HAD REACHED END-OF-LIFE STATUS. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728238 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-93174. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-93176. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH THE POCKET INFECTION AND THE SKIN OF THE DEVICE POCKET APPEARING RED, SWOLLEN, AND EXPERIENCING DISCHARGE. ADDITIONALLY, VEGETATION WAS VISUALIZED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD AFTER THE LEADS WERE EXTRACTED. THE PHYSICIAN EXPLANTED THE ACTIVE SYSTEM - IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL LEAD AND THE RIGHT VENTRICULAR LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 18315479 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION DEVELOPED. THE PHYSICIAN DETERMINED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS CAUSING TOO MUCH TENSION ON THE POCKET RESULTING IN INFECTION. THE ICD WAS EXPLANTED, AND POCKET DEBRIDEMENT WAS PERFORMED. THE ICD WAS REPLACED LATER ON (B)(6) 2023. PATIENT CONDITION WAS STABLE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17852979 ↗
• InjuryAug 8, 2023Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND DEVICE WAS NOT ABLE TO INTERROGATE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481033 ↗
• InjuryApr 24, 2023Premature 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. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797550 ↗
• MalfunctionMar 30, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED INAPPROPRIATE SHOCKS AFTER REACHING ELECTIVE REPLACEMENT INDICATOR AND WENT INTO BACK UP MODE. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645675 ↗
• InjuryMar 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC WITH DEVICE MIGRATION NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2023. NO ADDITIONAL ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534792 ↗
• MalfunctionFeb 10, 2023Defective Device; Defective Device

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

  Patient problems: Insufficient Information

  MAUDE report 16358979 ↗
• MalfunctionFeb 3, 2023Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP OPERATION AFTER MRI EXAMINATION. FURTHER INFORMATION WAS REQUESTED HOWEVER WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300687 ↗
• InjuryJan 31, 2023Premature Discharge of Battery; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-PATIENT AT THE HOSPITAL. UPON DEVICE INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP MODE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275295 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-03120 AND 2017865-2023-03121. IT WAS REPORTED THAT THE PATIENT'S ATRIAL LEAD DISLODGED. THE PATIENT WAS SCHEDULED FOR LEAD REVISION. DURING THE PROCEDURE, INFECTION WAS NOTED. IT WAS FURTHER NOTED THAT THE ATRIAL LEAD WAS FRACTURED AND THE RIGHT VENTRICULAR LEAD WAS FOUND TO HAVE EXTERNALIZED CONDUCTORS. THE FULL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS EXTRACTED. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16272437 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-00424, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-00426. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH AN INFECTION. ON (B)(6) 2022, THE PHYSICIAN EXPLANTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, THE RIGHT VENTRICULAR (RV) LEAD, AND THE ATRIAL LEAD. THE PATIENT CONDITION WAS STABLE

  Patient problems: Unspecified Infection

  MAUDE report 16103991 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-47138, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-47139. IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD EXPLANTED AND REPLACED DUE TO INFECTION. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15883693 ↗
• MalfunctionNov 7, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH BACK-UP VVI MODE NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, DUE TO HARDWARE RESET. CORRECTIVE PROGRAMMING CHANGES WERE MADE TO RESTORE THE DEVICE FUNCTION. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749639 ↗
• MalfunctionOct 6, 2022Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND AWAITING EXPLANT. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552000 ↗
• MalfunctionOct 5, 2022High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED DURING AN IMPLANT PROCEDURE ON (B)(6) 2022, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH AN ATRIAL PORT CONNECTION PROBLEM AND HIGH PACING IMPEDANCE. THE ICD WAS REPLACED WITHIN THE SAME OPERATION. POST-PROCEDURE THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545340 ↗
• InjuryOct 1, 2022Premature 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. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524479 ↗