Fortify Assura™ CD2257-40QRecalls & reported problems

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 05414734505550), received between Jun 12, 2018 and May 16, 2024 — classified as 4 deaths, 188 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (100 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE DEVICE WAS EXPLANTED PROPHYLACTICALLY. INITIAL INFORMATION INDICATES THE DEVICE MAY HAVE BEEN PENDING PROPHYLACTIC EXPLANT THOUGH THIS COULD NOT BE CONFIRMED. THE DEVICE WAS RECEIVED (B)(6), 2024, INDICATING IT WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19337566 ↗
• MalfunctionDec 19, 2023Defective Device; Defective Device

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

  Patient problems: Insufficient Information

  MAUDE report 18361403 ↗
• MalfunctionNov 13, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD GONE INTO BACKUP MODE. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118570 ↗
• MalfunctionOct 17, 2023Over-Sensing; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-49995. IT WAS REPORTED A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ATRIAL LEAD PRESENTED WITH OVERSENSING NOISE. NO CHANGES WERE REPORTED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949635 ↗
• InjuryAug 9, 2023Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  NEW INFORMATION RECEIVED NOTES THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490324 ↗
• InjuryJun 12, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH A BATTERY PERFORMANCE ALERT (BPA). THE ICD WAS EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107879 ↗
• InjuryApr 21, 2023Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790163 ↗
• MalfunctionMar 3, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR REMOTE FOLLOW-UP VIA MERLIN.NET WITH A NON-SUSTAINED EPISODE RECORDED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. A REVIEW OF THE EPISODE REVEALED R- WAVE VARIABILITY THAT RESULTED IN UNDER-SENSING. PROGRAMMING INTERVENTIONS WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479771 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-02324, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-02325. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL DUE TO INFECTION. A TRANSESOPHAGEAL ECHOCARDIOGRAPH (TEE) WAS PERFORMED WHICH SHOWED VEGETATION ON THE PATIENT'S LEADS. THE ENTIRE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16181114 ↗
• InjuryDec 23, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY ON (B)(6) 2022 WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AT ELECTIVE REPLACEMENT INDICATOR (ERI), DESPITE HAVING HAD 9 MONTHS OF REMAINING LONGEVITY DURING THE LAST CHECK IN (B)(6) 2022. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT'S ICD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045630 ↗
• MalfunctionDec 13, 2022Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR R-WAVE OVERSENSING THAT RESULTED IN INAPPROPRIATE MODE SWITCH. THE DEVICE WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971605 ↗
• InjuryNov 4, 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 NOT DEPENDENT AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729282 ↗
• InjuryOct 7, 2022Low impedance; Inappropriate or Unexpected Reset; Low impedance; Inappropriate or Unexpected Reset

  IT WAS REPORTED A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED IN BACKUP VVI MODE. THE DEVICE WAS RESTORED AND LOW DEFIBRILLATION IMPEDANCE WAS NOTED. THE PATIENT WAS EXTERNALLY DEFIBRILLATED TO RESTORE NORMAL RHYTHM. FOLLOWING THIS EVENT, THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 15566539 ↗
• InjurySep 30, 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 THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510305 ↗
• InjurySep 28, 2022Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH INAPPROPRIATE SHOCK DUE TO INCORRECT INTERPRETATION OF SIGNAL. NO CHANGES WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496433 ↗
• MalfunctionSep 27, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED POST-PACED T-WAVE OVERSENSING ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO CHANGES OR INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491258 ↗
• MalfunctionSep 12, 2022Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH EPISODES OF INAPPROPRIATE AUTOMATIC MODE SWITCH CAUSED BY FAR-FIELD R WAVE OVER-SENSING RECORDED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PROGRAMMING INTERVENTIONS WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403247 ↗
• InjurySep 7, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND REVIEW OF MERLIN ON-DEMAND SHOWED THE DEVICE DELIVERED INAPPROPRIATE SHOCK DUE TO EMI. THE PATIENT EXPERIENCED NO ISSUES AFTER THE SHOCK AND IS DOING FINE. NO INTERVENTION OR PROGRAMMING NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370021 ↗
• MalfunctionAug 3, 2022Defective Device; Defective Device

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

  Patient problems: Insufficient Information

  MAUDE report 15161253 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15606. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A DEVICE SYSTEM EXTRACTION DUE TO CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) - RELATED ENDOCARDITIS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 15061589 ↗
• InjuryJun 20, 2022Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14749682 ↗
• InjuryJun 14, 2022Failure to Capture; Incorrect Measurement; Low impedance; Failure to Capture; Incorrect Measurement; Low impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-12161. IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC FOR AN EXPLANT PROCEDURE. EXAMINATION OF THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)WAS FOUND TO HAVE EXHIBITED A DIAGNOSTIC ANOMALY, AS THE DEVICE WAS NOT ABLE TO RETURN A HIGH VOLTAGE IMPEDANCE READING. ADDITIONAL MALFUNCTIONS OF LOW PACING IMPEDANCE AND LOSS OF CAPTURE WERE NOTED ON THE DEVICE. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE MALFUNCTIONS OF HIGH CAPTURE THRESHOLDS AND INSULATION BREAK. THE RV LEAD WAS CAPPED AND THE ICD WAS EXPLANTED ON (B)(6) 2022. BOTH THE ICD AND RV LEAD WERE REPLACED. NO PATIENT CONSEQUENCES WERE REPORTED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683214 ↗
• InjuryJun 1, 2022Premature Discharge of Battery; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Inappropriate or Unexpected Reset

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. IT WAS ALSO NOTED THAT THE DEVICE WAS IN BACKUP MODE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566374 ↗
• InjuryApr 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC FOR A DEVICE EXPLANT PROCEDURE. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO HAVE AN UNSPECIFIED MALFUNCTION. THE ICD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN UNKNOWN CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14132583 ↗
• InjuryFeb 24, 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 BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13594582 ↗