Fortify Assura™ CD1357-40QRecalls & 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 implanted defibrillator that delivers shocks to correct irregular heart rhythms. Many reports describe batteries running down early, unexpected device resets, and sensing problems, and some mention inappropriate shocks or infections. The records include 1,926 reports, 1,291 injuries and 35 deaths, and 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
- 1,933
- Deaths reported
- 35
- Injuries reported
- 1,294
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,933 adverse event reports that list this exact device (DI 05414734507974), received between Feb 26, 2018 and Sep 24, 2026 — classified as 35 deaths, 1,294 injuries, 604 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (513 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 Battery513
- Battery Problem441
- Adverse Event Without Identified Device or Use Problem263
- Inappropriate or Unexpected Reset190
- Over-Sensing174
- Inappropriate/Inadequate Shock/Stimulation155
- Failure to Interrogate126
- Incorrect Interpretation of Signal94
Patient problems
- No Clinical Signs, Symptoms or Conditions763
- No Known Impact Or Consequence To Patient660
- Unspecified Infection165
- Insufficient Information86
- No Consequences Or Impact To Patient75
- Therapeutic Effects, Unexpected65
- Arrhythmia52
- Discomfort46
Recent adverse event reports
The 25 most recent of 1,933 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Failure to Convert Rhythm
It was discovered via remote transmission that the Implantable Cardioverter Defibrillator (ICD) exhibited a failure to convert patient arrythmia due to unacceptable defibrillation threshold. The patient was externally defibrillated. The patient was stable.
Patient problems: Arrhythmia
MAUDE report 50885585 ↗MalfunctionSep 18, 2026Inappropriate or Unexpected Reset
It was reported that the Implantable Cardioverter Defibrillator (ICD) had gone into backup mode. No intervention was reported and patient condition was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823752 ↗MalfunctionSep 10, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722318 ↗InjurySep 4, 2026Premature Discharge of Battery; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50622748 ↗MalfunctionSep 3, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596358 ↗InjurySep 2, 2026Failure to Convert Rhythm
It was reported that the device failed to deliver high voltage therapy during an episode of ventricular fibrillation. Reprogramming was anticipated to resolve the event. The patient was stable and there were no adverse consequences.
Patient problems: Arrhythmia
MAUDE report 50571582 ↗MalfunctionSep 1, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) failed to be interrogated. No intervention was performed. The patient had no adverse consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547714 ↗MalfunctionAug 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509134 ↗MalfunctionAug 28, 2026Premature Discharge of Battery; Inappropriate or Unexpected Reset; Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508295 ↗InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was admitted to the hospital with a fever and signs of infection. Vegetation was noted on the right ventricular (RV) lead via diagnostic imaging. It was also observed that the RV lead exhibited noise oversensing, resulting in pacing inhibition. The Implantable Cardioverter Defibrillator (ICD) and the RV lead were explanted on (b)(6) 2026. The patient was in stable condition.
Patient problems: Fever; Unspecified Infection
MAUDE report 50383208 ↗MalfunctionAug 21, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50380779 ↗MalfunctionAug 19, 2026Under-Sensing
It was reported that the implantable cardioverter defibrillator exhibited undersensing. Further information was requested however, was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50314612 ↗MalfunctionAug 13, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239848 ↗MalfunctionAug 10, 2026Inappropriate or Unexpected Reset
It was reported that backup VVI with no backup defibrillation operation therapy available was observed on the Implantable Cardioverter Defibrillator (ICD).
Patient problems: Insufficient Information
MAUDE report 50194201 ↗InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented in the hospital due to a Methicillin-resistant Staphylococcus aureus (MRSA) infection. In response, the physician elected to explant the entire pacing system, including the implantable cardioverter-defibrillator (ICD) and the right ventricular (RV) lead, on (b)(6) 2026. No patient condition was reported.
Patient problems: Unspecified Infection
MAUDE report 50189919 ↗InjuryJul 27, 2026Failure to Deliver Shock/Stimulation; Under-Sensing
It was reported that the patient experienced arrhythmia and syncope episode and presented in the emergency room. It was noted that the Implantable Cardioverter Defibrillator (ICD) exhibited under-sensing and failed to deliver therapy. Programming changes were made. The patient was in stable condition.
Patient problems: Arrhythmia; Syncope/Fainting
MAUDE report 50037868 ↗MalfunctionJul 7, 2026Under-Sensing
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25733280 ↗MalfunctionJun 2, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTROMAGNETIC INTERFERENCE OVERSENSING. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT AND CONTINUED TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364363 ↗MalfunctionMay 29, 2026Over-Sensing
IT WAS REPORTED THAT POST-SENSED T-WAVE OVERSENSING (PSTWOS) WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, THE RV LEAD EXHIBITED DECREASED SENSING. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25338184 ↗MalfunctionMay 12, 2026Over-Sensing
IT WAS REPORTED THAT DURING A CLINIC DEVICE INTERROGATION, OVERSENSING DUE TO POSSIBLY MYOPOTENTIAL OVERSENSING WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A PROGRAMMING CHANGE WAS MADE. THE PATIENT WAS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149524 ↗InjuryMay 8, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BATTERY PERFORMANCE ALERT. THE ICD WAS EXPLANTED. THE PATIENT'S CONDITION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126084 ↗MalfunctionMay 6, 2026Failure to Interrogate; Interrogation Problem
NEW INFORMATION RECEIVED INDICATES THAT RADIO FREQUENCY (RF) TELEMETRY WAS UNAVAILABLE FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25107991 ↗InjuryMay 4, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED A DIAGNOSTICS ANOMALY. IT WAS NOTED THAT THE PATIENT RECEIVED SEVERAL SHOCKS DURING SURGERY FROM MOST LIKELY CAUTERY OVER SENSING. A FIRMWARE DOWNLOAD WAS PERFORMED TO RESET THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064829 ↗MalfunctionApr 22, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO UNRELATED HEALTH ISSUES. A DEVICE INTERROGATION WAS PERFORMED AND FOUND THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED. PROGRAMMING CHANGES WERE MADE TO RESET THE ICD. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956403 ↗InjuryApr 17, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
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 OVER-SENSED NOISE WHICH RESULTED IN THE DELIVERY OF INAPPROPRIATE THERAPY. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911850 ↗
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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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