Fortify Assura™ CD1257-40Recalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillator VVEV VVIR · Class 3 · Implant
All models of Fortify Assura (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Fortify Assura defibrillator has 86 adverse event reports: 58 injuries, 26 malfunctions and 2 deaths. The reports mostly describe batteries discharging early, and many describe the device being removed after a battery performance alert, with some reporting unexpected resets. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 86
- Deaths reported
- 2
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 05414734505468), received between Jun 11, 2018 and Feb 26, 2024 — classified as 2 deaths, 58 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (25 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.
Reports received per month
Most reported problems
Device problems
- Premature Discharge of Battery25
- Battery Problem23
- Inappropriate or Unexpected Reset11
- Over-Sensing8
- Adverse Event Without Identified Device or Use Problem6
- Failure to Interrogate5
- Defective Device3
- Failure to Deliver Shock/Stimulation3
Patient problems
- No Known Impact Or Consequence To Patient40
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information3
- No Consequences Or Impact To Patient3
- Unspecified Infection3
- Arrhythmia2
- Death2
- Syncope2
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2024Premature 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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A FAILURE TO INTERROGATE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778710 ↗InjuryFeb 3, 2024Premature 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 CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18637113 ↗InjuryJan 15, 2024Premature 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18512477 ↗InjuryDec 5, 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. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271756 ↗InjurySep 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 ON (B)(6) 2023. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17805345 ↗InjuryAug 29, 2023Tactile Prompts/Feedback; Tactile Prompts/Feedback
VOLUNTARY MEDWATCH RECEIVED STATES THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS VIBRATING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17643131 ↗InjuryAug 22, 2023Signal Artifact/Noise; Signal Artifact/Noise
NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17600518 ↗MalfunctionJun 2, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 17046388 ↗InjuryApr 25, 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. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16809914 ↗InjuryJan 31, 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. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16271242 ↗MalfunctionJan 25, 2023Premature Discharge of Battery; Premature Discharge of Battery
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN. THE DEVICE WILL BE MONITORED UNTIL THE BATTERY REACHES ERI DUE TO THE PATIENT'S AGE AND NO HISTORY OF DEVICE ISSUES. PROGRAMMING CHANGES WERE MADE. NO PLANS FOR REPLACEMENT AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16243853 ↗InjuryDec 28, 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 AND REPLACED. PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16062523 ↗InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXPLANTED DUE TO INFECTION. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 15879663 ↗InjuryOct 21, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. NO CHANGES OR INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15651789 ↗InjuryOct 19, 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. THERE WERE NO PATIENT CONSEQUENCES. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15631716 ↗MalfunctionSep 1, 2022Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON INTERROGATION, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO HAVE EXHIBITED POST-PACED T-WAVE OVER-SENSING. CORRECTIVE PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15339206 ↗MalfunctionAug 24, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 15287045 ↗InjuryApr 20, 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 CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14163562 ↗MalfunctionApr 5, 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. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14015980 ↗InjuryApr 5, 2022High impedance; Over-Sensing; Pacing Problem; Failure to Sense; Inappropriate/Inadequate Shock/Stimulation; High impedance; Over-Sensing; Pacing Problem; Failure to Sense; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON EXAMINATION OF THE TRANSMISSION, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO HAVE EXHIBITED OVER-SENSING OF NOISE, INAPPROPRIATE SHOCK, HIGH DEFIBRILLATION IMPEDANCE, FAILURE TO SENSE, AND AN OUTPUT RATE ISSUE. NO INTERVENTION WAS REPORTED. THE PATIENT WAS IN UNKNOWN CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14015453 ↗InjuryMar 16, 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 AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13782104 ↗MalfunctionMar 15, 2022Premature Discharge of Battery; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED DUE TO DEVICE BEING IN BACKUP MODE. THE ICD WAS OUT OF BATTERY. NO INTERVENTIONS WERE REPORTED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13772166 ↗InjuryDec 15, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED VIA REMOTE TRANSMISSION. REVIEW OF TRANSCRIPTS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP VVI. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13011897 ↗InjuryDec 7, 2021Premature 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 AND AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12957978 ↗InjuryOct 29, 2021Premature 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. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12724791 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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