Fortify Assura™ CD1357-40CRecalls & reported problems

Summary

The FDA's MAUDE database contains 615 adverse event reports that list this exact device (DI 05414734507943), received between Jun 14, 2018 and May 14, 2026 — classified as 18 deaths, 389 injuries, 208 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (157 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 615 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY. PROGRAMMING CHANGES WERE DISCUSSED, NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177849 ↗
• InjuryMay 1, 2026Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND VENTRICULAR TACHYCARDIA (VT). REVIEW OF THE TRANSMISSION REVEALED LOSS OF HIGH-VOLTAGE (HV) THERAPY ON THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS THE VT WAS OUTSIDE OF THE DETECTION RATE. PROGRAMMING CHANGES WERE DISCUSSED, NO INTERVENTION WAS REPORTED. THE PATIENT¿S CONDITION REMAINED STABLE.

  Patient problems: Arrhythmia; Syncope/Fainting

  MAUDE report 25062212 ↗
• MalfunctionFeb 13, 2026Intermittent Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED EPISODES OF INTERMITTENT CAPTURE. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333562 ↗
• MalfunctionJan 30, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 24221408 ↗
• InjuryJan 28, 2026Premature 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 AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205101 ↗
• MalfunctionJan 21, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED INAPPROPRIATE SHOCK DUE TO INCORRECT INTERPRETATION OF SIGNAL. IT WAS NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SVT. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140310 ↗
• MalfunctionJan 12, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A NOISE PROBLEM. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032629 ↗
• InjuryJan 9, 2026Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED CHARGE TIME OUT. THE PHYSICIAN EXPLANTED AND REPLACED THE ICD. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030821 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 24016353 ↗
• MalfunctionJan 7, 2026Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED UNDER-SENSING. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992864 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL DUE TO INFECTION. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 23986862 ↗
• InjuryDec 24, 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. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891127 ↗
• MalfunctionDec 8, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH MISSING DIAGNOSTIC MEASUREMENTS OF IMPEDANCE AND CHARGE TIME NOTED DURING HIGH VOLTAGE THERAPY DELIVERY, NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INTERVENTION WAS REPORTED AND THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752272 ↗
• MalfunctionDec 3, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) RECORDED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). REVIEW OF STORED ELECTROGRAMS REVEALED LOSS OF CAPTURE. NO PATIENT SYMPTOMS WERE REPORTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711305 ↗
• MalfunctionNov 21, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT POST-PACED T-WAVE OVERSENSING (PPTWOS) WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623741 ↗
• MalfunctionNov 20, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP. AN INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVEALED VENTRICULAR OVER-SENSING. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 23606104 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO THE HOSPITAL DUE TO INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD WERE EXPLANTED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23307767 ↗
• InjuryOct 15, 2025Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED SLOW CAPACITOR MAINTENANCE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296486 ↗
• InjurySep 11, 2025Failure to Interrogate; Inappropriate or Unexpected Reset; Failure to Interrogate; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. A DEVICE INTERROGATION WAS PERFORMED AND REVEALED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INAPPROPRIATELY GONE INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED. IT WAS NOTED THAT THE BACKUP OPERATION WAS CAUSED BY POWER ON RESET (POR). THE ICD WAS ATTEMPTED TO BE RESET BUT WAS UNSUCCESSFUL. THE PATIENT LATER PRESENTED AGAIN FOR FOLLOW UP WHERE IT WAS DISCOVERED THAT THEIR ICD FAILED TO BE INTERROGATED. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028261 ↗
• InjurySep 3, 2025Premature Discharge of Battery; Failure to Interrogate; Data Problem; Premature Discharge of Battery; Failure to Interrogate; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW UP. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED, AND AN ERROR MESSAGE WAS DISPLAYED. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956882 ↗
• MalfunctionAug 18, 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). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835837 ↗
• InjuryAug 7, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED CHARGE TIME LIMIT REACHED. THE ICD WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739549 ↗
• MalfunctionJul 18, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACK-UP MODE DUE TO A SOFTWARE RELATED RESET. THE ICD WAS SUCCESSFULLY REPROGRAMMED AND RESTORED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22547087 ↗
• InjuryJul 16, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM DUE TO INAPPROPRIATE SHOCK RECEIVED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE MADE. PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521823 ↗
• InjuryJul 16, 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. ICD WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516885 ↗