Fortify Assura™ CD1257-40QRecalls & 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 is an implantable defibrillator. Its 250 reports often describe battery problems, including batteries draining early, and some describe over-sensing and unexpected resets. The reports include 171 injuries and 4 deaths. 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
- 250
- Deaths reported
- 4
- Injuries reported
- 171
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 05414734505475), received between Jun 12, 2018 and Mar 12, 2024 — classified as 4 deaths, 171 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (97 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
- Battery Problem97
- Premature Discharge of Battery73
- Inappropriate or Unexpected Reset22
- Over-Sensing22
- Adverse Event Without Identified Device or Use Problem14
- Inappropriate/Inadequate Shock/Stimulation12
- Failure to Interrogate9
- Under-Sensing9
Patient problems
- No Known Impact Or Consequence To Patient123
- No Clinical Signs, Symptoms or Conditions93
- No Consequences Or Impact To Patient15
- Insufficient Information8
- Therapeutic Effects, Unexpected6
- Arrhythmia5
- Discomfort2
- No Information2
Recent adverse event reports
The 25 most recent of 250 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2024Premature Discharge of Battery; Premature Discharge of Battery
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN. NO INTERVENTION WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18887836 ↗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 CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18266786 ↗InjuryNov 30, 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 IN STABLE CONDITION POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18238687 ↗MalfunctionNov 12, 2023Inappropriate 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). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18117470 ↗InjuryOct 23, 2023Over-Sensing; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO OVER-SENSING NOISE. PROGRAMMING CHANGES WERE MADE TO RESTORE NORMAL PARAMETERS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17991297 ↗MalfunctionOct 17, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED BATTERY PERFORMANCE ALERT ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO CHANGES OR INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17954197 ↗InjuryOct 13, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17931512 ↗MalfunctionOct 12, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 17927562 ↗InjurySep 19, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM. DEVICE INTERROGATION REVEALED POST-SENSED T-WAVE OVERSENSING 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 17773825 ↗InjuryAug 15, 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 17551991 ↗DeathJul 25, 2023Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem
RELATED MFR REPORT NUMBER: 2017865-2023-36683. FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN. THE CLINICIAN INDICATED THAT THE PATIENT HAD EXPIRED; THE CLINICIAN DID NOT ALLEGE THAT THE PATIENT DEATH IS RELATED TO ABBOTT PRODUCTS OR PROCEDURE INVOLVING ABBOTT PRODUCTS. THE CAUSE OF DEATH IS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17391280 ↗MalfunctionJul 14, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 17330146 ↗InjuryJun 26, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE DUE TO HARDWARE RESET. LOSS OF DEFIBRILLATION THERAPY WAS ALSO NOTED DUE TO BACKUP. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17201498 ↗MalfunctionApr 3, 2023Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED UNDER-SENSING. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16665301 ↗MalfunctionMar 27, 2023Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP WITH VENTRICULAR UNDER-SENSING EXHIBITED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 16618326 ↗MalfunctionMar 21, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO A SHOCK THAT WAS DELIVERED. DEVICE INTERROGATION REVEALED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN BACKUP MODE. PROGRAMMING CHANGES WERE PERFORMED TO RESTORE THE ICD. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16582662 ↗InjuryFeb 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 DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16441115 ↗InjuryFeb 7, 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 NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16312410 ↗InjuryJan 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 ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16235438 ↗MalfunctionJan 24, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. PROGRAMMING CHANGES WERE PERFORMED TO RESTORE THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16233631 ↗InjuryJan 19, 2023Premature Discharge of Battery; Premature Discharge of Battery
NEW INFORMATION NOTED THAT THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16211801 ↗InjuryJan 1, 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 HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16081406 ↗InjuryDec 29, 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 5 DEC 2022. THE PATIENT WAS IN UNKNOWN CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16074897 ↗MalfunctionNov 13, 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. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15786292 ↗MalfunctionNov 13, 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 IS AWAITING EXPLANT. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15786020 ↗
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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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