UNIFYRecalls & reported problems across all models
St. Jude Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 234
- Deaths reported
- 10
- Injuries reported
- 167
- Recalls
- 0
We found 2 models of UNIFY by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 234 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Apr 17, 2026 — classified as 10 deaths, 167 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (42 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported UNIFY problems
Device problems
- Adverse Event Without Identified Device or Use Problem81
- Battery Problem42
- Premature Discharge of Battery26
- Inappropriate or Unexpected Reset22
- Inappropriate/Inadequate Shock/Stimulation18
- Over-Sensing16
- Failure to Interrogate12
- Signal Artifact/Noise8
Patient problems
- No Known Impact Or Consequence To Patient121
- No Clinical Signs, Symptoms or Conditions31
- Unspecified Infection29
- Therapeutic Effects, Unexpected15
- No Consequences Or Impact To Patient10
- Pocket Erosion8
- Death7
- No Information7
UNIFY models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UNIFY™ CD3231-40Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)8 deaths148 reports
- UNIFY™ CD3231-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 deaths86 reports
Recent UNIFY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP OPERATION. IT WAS NOTED THAT IT WAS UNKNOWN WHAT CAUSED THE DEVICE TO GO INTO BACKUP MODE. PROGRAMMING CHANGES WERE PERFORMED TO RESTORE THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24914291 ↗MalfunctionApr 1, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN MRI PROCEDURE, RESULTING IN BACKUP VVI MODE WITH NO BACKUP DEFIBRILLATION OPERATION. THE DEVICE WAS NOT MAGNETIC RESONANCE (MR) CONDITIONAL. THE DEVICE WAS RESTORED TO NORMAL OPERATION. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753116 ↗MalfunctionMar 25, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT. DURING PROCEDURE, THE SET SCREW OF THE ICD FAILED TO BE TIGHTENED. THE ICD WAS NOT IMPLANTED, AND A REPLACEMENT WAS IMPLANTED ON (B)(6) 2026. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688939 ↗MalfunctionDec 23, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP IN THE CLINIC. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE WITH HIGH VOLTAGE THERAPY DISABLED. PROGRAMMING CHANGES WERE MADE, AND THE ICD WAS RESTORED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874608 ↗InjuryNov 10, 2025Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A PATIENT PRESENTED WITH INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING DUE TO INCORRECT INTERPRETATION OF SIGNAL. CORRECTIVE PROGRAMMING CHANGES WERE MADE. NO FURTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Discomfort
MAUDE report 23512817 ↗MalfunctionNov 5, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP MODE. IT WAS THEN DISCOVERED THAT THE ICD EXHIBITED PREMATURE BATTERY DEPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477985 ↗InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING REPEATED FEVER FOR THE PAST TWO YEARS SINCE THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) IMPLANT. THE PHYSICIAN WAS UNSURE IF THE INFECTION WAS RELATED TO ABBOTT DEVICE AND PROCEDURE. THE ICD, RIGHT VENTRICULAR (RV) LEAD, LEFT VENTRICULAR (LV) LEAD AND RIGHT ATRIAL (RA) LEADS WERE EXPLANTED AND NOT REPLACED. THE PATIENT IS RECOVERING FOLLOWING THE PROCEDURE.
Patient problems: Fever; Unspecified Infection
MAUDE report 22628441 ↗InjuryMar 3, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. BATTERY PERFORMANCE ALERT (BPA) WAS RECEIVED. THE PATIENT'S ICD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21503781 ↗InjurySep 10, 2024Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20183893 ↗MalfunctionAug 12, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT PATIENT PRESENTED FOR SCHEDULED PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT DEVICE HEADER'S SET SCREW WAS STRIPPED. THE DEVICE WAS ULTIMATELY NOT USED AND REPLACED. PATIENT WAS RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19961763 ↗InjuryJul 16, 2024Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT DURING THE PATIENTS REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19755301 ↗InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH AN UNSPECIFIED INFECTION. THE PHYSICIAN EXPLANTED THE SYSTEM- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICLE LEAD AND LEFT VENTRICLE LEAD. THE RA LEAD WAS REPLACED.
Patient problems: Unspecified Infection
MAUDE report 19235948 ↗MalfunctionJan 9, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING PROCEDURE IT WAS NOTED THAT THE SETSCREW FELL OFF THE PACEMAKER. THE PROCEDURE WAS COMPLETED USING A DIFFERENT PACEMAKER. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18480775 ↗DeathNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-72578. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-72579. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-72580. IT WAS REPORTED THAT THE PATIENT HAD DECEASED DUE TO AN UNKNOWN CAUSE. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18166347 ↗MalfunctionOct 27, 2023Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT INTO A BACKUP VVI HARDWARE RESET FOLLOWING A MAGNETIC RESONANCE INSURANCE (MRI) EXAM WHILE THE ICD WAS NOT MRI COMPATIBLE. THE MRI SYSTEM USED WAS A 1.5T MRI MACHINE. THE ISSUE WAS DISCOVERED AT A FOLLOW UP IN CLINIC. A DEVICE DOWNLOAD OR RESET WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18026314 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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