UNIFY™ CD3231-40Recalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillatorVVED DDDRV · Class 3 · Implant
Quick summary
This St. Jude Medical Unify CRT-D is an implanted heart device that paces the heart and delivers shocks. Its 148 reports describe the battery draining early, the device resetting or switching to backup mode, and inappropriate shocks, and some mention infections. The reports include 99 injuries and 8 deaths. Reports rose to 6 in the last 12 months from 2 in the 12 months before. 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
- 148
- Deaths reported
- 8
- Injuries reported
- 99
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 05414734504362), received between Jun 20, 2018 and Apr 17, 2026 — classified as 8 deaths, 99 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (19 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem54
- Premature Discharge of Battery19
- Battery Problem18
- Inappropriate or Unexpected Reset17
- Inappropriate/Inadequate Shock/Stimulation12
- Over-Sensing11
- Failure to Interrogate7
- Loose or Intermittent Connection5
Patient problems
- No Known Impact Or Consequence To Patient53
- No Clinical Signs, Symptoms or Conditions28
- Unspecified Infection27
- Therapeutic Effects, Unexpected10
- No Consequences Or Impact To Patient7
- Pocket Erosion7
- Death6
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 148 reports, 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 ↗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 ↗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 ↗InjurySep 18, 2023High impedance; Loose or Intermittent Connection; Connection Problem; High impedance; Loose or Intermittent Connection; Connection Problem
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED HIGH PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN CONSIDERS HIGH PACING IMPEDANCE IS DUE TO INADEQUATE INSERTION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HEADER. DURING REPOSITIONING, THE SET SCREW WAS UNABLE TO BE TIGHTENED. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17765516 ↗InjuryAug 25, 2023Break; Inappropriate or Unexpected Reset; Break; Inappropriate or Unexpected Reset
IT WAS REPORTED, A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED IN BACKUP VVI MODE. FOR AN UNKNOWN REASON. THE INTERNAL COMPONENTS WERE ALSO FOUND DAMAGED. AND A RESET COULD NOT BE PERFORMED. THE DEVICE WAS EXPLANTED IN A PROCEDURE ON (B)(6) 2023. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17627668 ↗MalfunctionJul 6, 2023No Pacing; No Pacing
IT WAS REPORTED THAT DURING THE CHANGE OUT PROCEDURE, THE NEW PACEMAKER FAILED TO PRODUCE LOW VOLTAGE OUTPUT RESULTING IN THE PATIENT BECOMING BRADYCARDIC. UPON REPROGRAMMING, PACING WAS ABLE TO BE RESTORED TO NORMAL FUNCTION. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Patient problems: Arrhythmia
MAUDE report 17269140 ↗InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC TO HAVE THEIR ENTIRE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXPLANTED DUE TO AN UNSPECIFIED INFECTION. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 17051178 ↗InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-17927, RELATED MANUFACTURER REFERENCE NUMBER : 2017865-2023-17928, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-17929. IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH INFECTION AND SKIN EROSION AT DEVICE POCKET. THE DEVICE POCKET SITE WAS NOTED TO BE RED SINCE NOVEMBER 2022 AND RUPTURED ON (B)(6) 2023. THE LEFT VENTRICULAR LEAD WAS NOTED WITH HIGH CAPTURE THRESHOLD. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 16767488 ↗MalfunctionJan 26, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 16251198 ↗InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBERS: 2017865-2022-48604, 2017865-2022-48606, 2017865-2022-48607. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH AN INFECTION IDENTIFIED BY DISCHARGE AT THE IMPLANT SITE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: Unspecified Infection
MAUDE report 15974020 ↗MalfunctionDec 5, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 15921114 ↗MalfunctionOct 17, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT PRIOR TO IMPLANT, THE NOVEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS INAPPROPRIATELY IN BACK-UP OPERATION. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE ON (B)(6)2022. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15620761 ↗MalfunctionAug 4, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP MODE AND DEFIBRILLATION THERAPY WAS UNAVAILABLE. THE CAUSE OF THE RESET WAS UNKNOWN. THE DEVICE WAS REPROGRAMMED AND SUCCESSFULLY RESTORED BACK TO NORMAL SETTINGS. THE PATIENT WAS STABLE AND ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15163414 ↗MalfunctionJun 8, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WENT INTO BACKUP MODE DUE TO ELECTROMAGNETIC INTERFERENCE. LOSS OF DEFIBRILLATION THERAPY NOTED. THE DEVICE WAS ABLE TO RESET TO NORMAL SETTING BY PROGRAMMING INTERVENTION. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14634448 ↗MalfunctionMay 19, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 14437045 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.