Unify Assura™ CD3257-40Recalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of Unify Assura (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Unify Assura defibrillator has 108 adverse event reports, with 4 deaths and 44 injuries. Many reports describe the device sensing noise or muscle signals as heartbeats, battery problems, or unexpected resets, and some describe the device going into backup mode. 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
- 108
- Deaths reported
- 4
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 05414734505628), received between Jun 15, 2018 and Jan 25, 2023 — classified as 4 deaths, 44 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (36 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
- Over-Sensing36
- Battery Problem20
- Adverse Event Without Identified Device or Use Problem17
- Inappropriate or Unexpected Reset14
- Premature Discharge of Battery5
- Signal Artifact/Noise4
- Communication or Transmission Problem3
- Failure to Interrogate3
Patient problems
- No Known Impact Or Consequence To Patient80
- No Clinical Signs, Symptoms or Conditions8
- Death4
- Discomfort3
- No Information3
- No Consequences Or Impact To Patient2
- Unspecified Infection2
- Arrhythmia1
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 16244521 ↗MalfunctionJul 27, 2022Over-Sensing; Over-Sensing
IT WAS REPORTED THAT WHEN A PATIENT PRESENTED VIA A MERLIN@HOME TRANSMISSION, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DUE TO POST PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE NOT PERFORMED YET SINCE THE PATIENT DID NOT COME TO THE CLINIC. THE PATIENT IS FINE AND NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15112275 ↗InjuryJun 14, 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 14690039 ↗InjuryApr 8, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN BACKUP MODE. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053211 ↗MalfunctionMar 4, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT INTO BACKUP OPERATION DUE TO EVENT QUEUE OVERFLOW. PROGRAMMING CHANGES WERE MADE AND THE ICD WAS RESTORED. PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13677508 ↗MalfunctionMay 26, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC WITH EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO). UPON REVIEW, IT WAS NOTED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS OVER-SENSING MYOPOTENTIALS. THE OVERSENSING WAS REPRODUCIBLE WITH ISOMETRICS. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11882443 ↗MalfunctionFeb 11, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THE PATIENT PRESENTED REMOTELY WITH A NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODE DUE TO FAR P-WAVE OVERSENSING ON THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR. INTERVENTION DISCUSSED BUT NOT MADE AS OF YET. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11319060 ↗MalfunctionFeb 2, 2021Pacing Problem; Pacing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE. DURING THE PROCEDURE, THE DEVICE WAS PROGRAMMED TO ASYNCHRONOUS SETTINGS AND A VENTRICULAR SENSED MARKER WAS SEEN. WHEN THE PHYSICIAN APPLIED ELECTROCAUTERY, THE DEVICE INHIBITED PACING, WHICH WAS NOTED ON THE SURFACE ELECTROCARDIOGRAM. THE PHYSICIAN IMMEDIATELY REMOVED AND REPLACED THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11269318 ↗MalfunctionJan 21, 2021Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN UNRELATED CONDITION. UPON INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MULTIPLE EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING WERE NOTED TO BE STORED BY THE DEVICE. THE EPISODES WERE ATTRIBUTED TO NOISE CAUSED BY ELECTROMAGNETIC INTERFERENCE WITH THE PATIENT¿S LEFT VENTRICULAR ASSIST DEVICE. PROGRAMMING INTERVENTIONS WERE MADE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11211216 ↗InjuryOct 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS DEFECTIVE. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2013.
Patient problems: No Information
MAUDE report 10701880 ↗MalfunctionSep 30, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITING POST-PACED T-WAVE OVERSENSING RESULTING IN EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING. PROGRAMMING INTERVENTIONS WERE IN-CLINIC. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10607388 ↗InjurySep 23, 2020Battery Problem; Battery Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-14099. FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. PRIOR TO THE PROCEDURE, USING FLUOROSCOPY, THE PHYSICIAN NOTED EXTERNALIZED CONDUCTORS ON THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10575011 ↗InjuryAug 5, 2020Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10367544 ↗InjuryJul 24, 2020Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset
RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-07618. IT WAS REPORTED THAT THE PATIENT PRESENTED IN EMERGENCY ROOM, INAPPROPRIATE SHOCKS DUE TO BACKUP VVI ISSUE WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 10320566 ↗InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT'S CONDITION WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10241839 ↗MalfunctionJun 26, 2020Communication or Transmission Problem; Inappropriate or Unexpected Reset; Communication or Transmission Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, IT WAS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REVERTED TO BACKUP VVI. PROGRAMMING CHANGES AND DOWNLOAD COULD NOT BE PERFORMED DUE TO LOW BATTERY STATUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10203242 ↗InjuryJun 10, 2020Premature Discharge of Battery; Battery Problem; No Pacing; Premature Discharge of Battery; Battery Problem; No Pacing
FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAILED TO PACE AND IT WAS ALLEGED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10139006 ↗MalfunctionJun 1, 2020Battery Problem; Battery Problem
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.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10106002 ↗MalfunctionMay 26, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, IT WAS FOUND THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXHIBITING FAR R-WAVE OVER-SENSING THAT LED TO INAPPROPRIATE AUTOMATIC MODE SWITCHING. NO INTERVENTION WAS PERFORMED. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10088620 ↗MalfunctionApr 15, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET WITH AN ALERT OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR - ICD EXHIBITED POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE DISCUSSED. NO INTERVENTION WAS PERFORMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9963350 ↗InjuryApr 13, 2020Migration; Migration
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN ELECTIVE GENERATOR CHANGEOUT PROCEDURE WITH DISCOMFORT IN THE POCKET. THE PATIENT ALLEGED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THE PATIENT WAS DISCHARGED POST-PROCEDURE.
Patient problems: Discomfort
MAUDE report 9954387 ↗MalfunctionApr 3, 2020Failure to Capture; Failure to Capture
RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-04623. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR REPLACEMENT. THE PATIENT WAS PROGRAMMED VOO BEFORE THE OLDER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MODEL 3257 WAS DISCONNECTED. BOVIE WAS USED BY THE PHYSICIAN IN THE POCKET RESULTING IN TRUE LOSS OF CAPTURE AND ASYSTOLE. TELEMETRY SHOWED PACING OUTPUTS WERE CONSISTENT WITH VOO. THE LEADS WERE SWITCHED TO THE NEW ICD MODEL 3357 AND ELECTROCAUTERY RESULTED IN A SIMILAR ASYSTOLE WITH TELEMETRY SHOWING PACING. PROGRAMMING CHANGES TO INCREASE OUTPUT WERE MADE. ALL CHANGES RESULTED IN ASYSTOLE DESPITE PACING. THE PHYSICIAN OPTED TO PROCEED WITH THE IMPLANT SINCE THE ISSUE OCCURRED ACROSS BOTH GENERATORS AND SEEMED ONLY RELATED TO THE ELECTROCAUTERY (BOVIE) IN THE POCKET AND NOT TO THE DEVICE ITSELF. THE ASYSTOLE ONLY LASTED AS LONG AS THE BOVIE BURSTS ~ 2-3 SECONDS. THE PATIENT HAD NO ADVERSE EFFECTS, WAS STABLE AND NO INTERVENTION WAS NEEDED. VOO* - (ASYNCHRONOUS PACING MODE - PACING DELIVERED AT A FIXED RATE WITH NO SENSING TO PREVENT NOISE DETECTION BY ELECTROCAUTERY DURING PROCEDURE).
Patient problems: Arrhythmia
MAUDE report 9922384 ↗MalfunctionMar 3, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9781709 ↗InjuryFeb 18, 2020Communication or Transmission Problem; Inappropriate or Unexpected Reset; Communication or Transmission Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED VIA REMOTE TRANSMISSION. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP VVI MODE DUE TO EVENT QUEUE OVERFLOW. THE PATIENT WAS REPORTED TO HAVE FELT POOR DUE TO A LACK OF BIVENTRICULAR PACING SUPPORT. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Discomfort
MAUDE report 9722824 ↗DeathFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020- 01153. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020- 01154. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020- 01155. IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Death
MAUDE report 9706270 ↗
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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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