Fortify Assura™ CD2257-40Recalls & 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 Fortify Assura is an implantable defibrillator that treats abnormal heart rhythms with shocks and pacing. Many of its 190 reports describe battery problems, including early battery drain, along with sensing errors and unexpected shocks or resets. Some reports describe devices removed after battery performance alerts. There are 105 injury reports and 3 death reports. 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
- 190
- Deaths reported
- 3
- Injuries reported
- 105
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI 05414734505543), received between Jun 11, 2018 and Sep 11, 2023 — classified as 3 deaths, 105 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (50 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
Device problems
- Battery Problem50
- Over-Sensing43
- Premature Discharge of Battery34
- Adverse Event Without Identified Device or Use Problem18
- Inappropriate or Unexpected Reset13
- Inappropriate/Inadequate Shock/Stimulation13
- Under-Sensing11
- Defective Device10
Patient problems
- No Known Impact Or Consequence To Patient113
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information11
- No Consequences Or Impact To Patient9
- Therapeutic Effects, Unexpected7
- Unspecified Infection5
- Discomfort4
- Death3
Recent adverse event reports
The 25 most recent of 190 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 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'S CONDITION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17725772 ↗MalfunctionJul 21, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 17372506 ↗MalfunctionJul 20, 2023Defective Device; Defective Device
THE REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 17367149 ↗MalfunctionMar 30, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 16641080 ↗MalfunctionMar 20, 2023Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. DEVICE INTERROGATION REVEALED UNDER SENSING ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16579754 ↗InjuryNov 10, 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 IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15772455 ↗MalfunctionSep 24, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED BACKUP OPERATION ON THE PACEMAKER. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481229 ↗InjuryAug 11, 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 15210058 ↗MalfunctionJul 29, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 15127357 ↗InjuryJul 27, 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 IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15116257 ↗InjuryJul 12, 2022Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. IT WAS NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI TACHYCARDIA THERAPY (ATP) AND A 36 J SHOCK DUE TO ATRIAL FLUTTER. PROGRAMMING CHANGES WERE MADE. IN ADDITION, MEDICATION CHANGES WERE MADE BY THE PHYSICIAN. THE PHYSICIAN DID NOT BELIEVE THE SHOCK WAS DUE TO A PROBLEM WITH THE DEVICE BUT THAT REPROGRAMMING WAS NEEDED BASED ON THE PATIENTS NEWLY PRESENTED ATRIAL FLUTTER RHYTHM SO AS TO ENSURE THE PATIENT DID NOT RECEIVE ANY SHOCK FOR ATRIAL FLUTTER IN THE FUTURE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14987901 ↗MalfunctionJun 20, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS SUCCESSFULLY RESTORED THROUGH A FIRMWARE DOWNLOAD. THE PATIENT WAS ASYMPTOMATIC AND WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14743488 ↗InjuryMay 13, 2022Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS UNABLE TO INTERROGATE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14402604 ↗InjuryApr 15, 2022Inappropriate/Inadequate Shock/Stimulation; No Apparent Adverse Event; Inappropriate/Inadequate Shock/Stimulation; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THAT EXHIBITED INAPPROPRIATE SHOCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14121238 ↗MalfunctionApr 11, 2022Intermittent Capture; Intermittent Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED INTERMITTENT VENTRICULAR CAPTURE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14079508 ↗MalfunctionFeb 14, 2022Under-Sensing; Under-Sensing
IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED VENTRICULAR UNDER SENSING. REPROGRAMMING WAS DONE SUCCESSFULLY ON THE 7TH, AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13523089 ↗InjuryFeb 3, 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 IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13444762 ↗InjuryJan 31, 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 THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13394095 ↗MalfunctionDec 20, 2021Premature 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. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046283 ↗InjuryDec 11, 2021Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR A FOLLOW-UP AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY. DURING INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IT WAS NOTED THAT THE ICD DELIVERED INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATIONS WITH RAPID VENTRICULAR RESPONSE (RVR). PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Discomfort
MAUDE report 12981654 ↗InjuryNov 27, 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 AND REPLACED ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12879762 ↗MalfunctionNov 24, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR-R OVERSENSING. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12871034 ↗InjuryNov 22, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS OVERSENSING NOISE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12853681 ↗InjuryNov 16, 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 CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12818065 ↗InjuryOct 13, 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. NO PATIENT CONSEQUENCES REPORTED POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12624510 ↗
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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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