Unify Quadra™ CD3249-40Recalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of Unify Quadra (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Unify Quadra cardiac resynchronization defibrillator (CRT-D) is an implanted heart device that delivers pacing and shock therapy. The 65 reports mostly describe batteries draining sooner than expected, the device resetting on its own, and infection or breakdown at the skin pocket where it sits, sometimes requiring removal of the whole system. Reports include 6 deaths and 49 injuries. 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
- 65
- Deaths reported
- 6
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 05414734504539), received between Jun 13, 2018 and Sep 18, 2026 — classified as 6 deaths, 48 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (15 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem27
- Premature Discharge of Battery15
- Inappropriate or Unexpected Reset7
- Inappropriate/Inadequate Shock/Stimulation4
- Environmental Compatibility Problem3
- Battery Problem2
- Data Problem2
- Failure to Convert Rhythm2
Patient problems
- No Known Impact Or Consequence To Patient18
- No Clinical Signs, Symptoms or Conditions14
- Unspecified Infection12
- Pocket Erosion8
- Discomfort4
- Arrhythmia3
- Death3
- Embolism/Embolus2
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812853 ↗InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, RIGHT VENTRICULAR LEAD AND LEFT VENTRICLE LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 23919775 ↗InjuryJun 11, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22184872 ↗InjuryJan 20, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED DURING IN-CLINIC FOLLOW UP THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A PREMATURE BATTERY DEPLETION. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT WAS RECOVERING POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21191411 ↗InjuryAug 11, 2024Failure to Charge; Failure to Charge
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED CAPACITOR MAINTENANCE CHARGE TIME OUT ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958378 ↗MalfunctionMay 17, 2024Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP OPERATION DUE TO MRI EXAMINATION. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19347345 ↗MalfunctionMay 16, 2024Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS DONE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 19332173 ↗InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN AT INCISION SITE. IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BAG WAS RUPTURED AND EXUDED A SMALL AMOUNT OF YELLOW PUS. THE ICD WAS ERODED OUT OF THE POCKET. CULTURE WAS PERFORMED AND THE RESULTS WERE NEGATIVE. THE PHYSICIAN ELECTED TO EXPLANT THE ENTIRE SYSTEM. THE PATIENT CONDITION WAS STABLE.
Patient problems: Discomfort; Pocket Erosion
MAUDE report 19072224 ↗DeathDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94481; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94483; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94485; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94486; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94487; IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE NEWLY PLACED RIGHT ATRIAL (RA) EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE AND THE NEWLY PLACED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAILURE TO PACE. THE RA LEAD AND THE ICD WERE NOT IMPLANTED AND ALTERNATES NEAR AT HAND WERE IMPLANTED INSTEAD ON (B)(6) 2023 TO COMPLETE THE PROCEDURE. POST PROCEDURE, THE PATIENT WENT INTO A COMA AND EVENTUALLY PASSED AWAY DUE TO ACUTE PULMONARY EMBOLISM.
Patient problems: Embolism/Embolus; Syncope/Fainting
MAUDE report 18307456 ↗DeathDec 11, 2023No Pacing; No Pacing
RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94481; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94484; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94485; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94486; RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-94487. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE NEWLY PLACED RIGHT ATRIAL (RA) EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE AND THE NEWLY PLACED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAILURE TO PACE. THE RA LEAD AND THE ICD WERE NOT IMPLANTED AND ALTERNATES NEAR AT HAND WERE IMPLANTED INSTEAD ON (B)(6) 2023 TO COMPLETE THE PROCEDURE. POST PROCEDURE, THE PATIENT WENT INTO A COMA AND EVENTUALLY PASSED AWAY DUE TO ACUTE PULMONARY EMBOLISM.
Patient problems: Embolism/Embolus; Syncope/Fainting
MAUDE report 18307454 ↗InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH INFECTION AND SKIN EROSION AT DEVICE POCKET SITE. THE DEVICE POCKET WAS NOTED, TO SWELLING, ULCERATION AND DISCHARGE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND POCKET DEBRIDEMENT. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR LEAD (RV) AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED. INFORMATION RECEIVED NOTES, THE ICD WAS RE-IMPLANTED AGAIN ON (B)(6) 2023. AFTER SUPPOSED APPROPRIATE STERILIZATION. THE RA, RV AND LV LEADS WERE REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 18098353 ↗DeathNov 8, 2023Failure to Convert Rhythm; Adverse Event Without Identified Device or Use Problem; Failure to Convert Rhythm; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-51923. IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR ARRHYTHMIA'S CULMINATING IN THE PATIENT BEING DECEASED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATION AND RIGHT VENTRICULAR LEAD MAY HAVE FAILED TO SUCCESSFULLY CONVERT THE VENTRICULAR ARRHYTHMIA AND IT IS UNKNOWN IF THEY CONTRIBUTED TO THE PATIENT'S DEATH.
Patient problems: Arrhythmia
MAUDE report 18094568 ↗InjuryOct 30, 2023Premature Discharge of Battery; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Interrogation Problem; Premature Discharge of Battery; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Interrogation Problem
IT WAS REPORTED, THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON EVALUATION, IT WAS FOUND, THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. IT WAS ALSO NOTED, THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCK. THE DEVICE WAS NOT ABLE TO BE INTERROGATED, DUE TO BACKUP MODE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18033836 ↗InjurySep 20, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17780577 ↗InjurySep 14, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO VENTRICULAR TACHYCARDIA (VT) STORM. IT WAS DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP OPERATION. THE DEVICE WAS SUCCESSFULLY REPROGRAMMED VIA PROGRAMMING; HOWEVER, THE BATTERY WAS CLOSE TO ELECTIVE REPLACEMENT INDICATOR. IT WAS BELIEVED THAT THE DEVICE ENTERED BACKUP OPERATION AFTER MULTIPLE HIGH VOLTAGE SHOCKS WERE DELIVERED TO TREAT VT STORM. THE PATIENT WAS SCHEDULED FOR REPLACEMENT AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE.
Patient problems: Arrhythmia
MAUDE report 17748625 ↗MalfunctionMay 15, 2023Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP MODE. IT WAS NOTED THAT THE PATIENT HAD UNDERWENT A MAGNETIC RESONANCE EXAMINATION CAUSING THE BACKUP MODE. PROGRAMMING WAS PERFORMED, AND THE DEVICE WAS SUCCESSFULLY RESTORED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931009 ↗InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-17818. RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-17820. RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-17821. IT WAS REPORTED THAT A PATIENT PRESENTED FOR AN IMPLANTATION ON (B)(6) 2023. DURING THE IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, AFTER NUMEROUS ATTEMPTS THE PATIENT SUFFERED FROM HEART FAILURE. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITHOUT IMPLANTING THE RV LEAD. ON (B)(6) 2023, THE PHYSICIAN ELECTED TO IMPLANT A DIFFERENT RV LEAD. THE PATIENT IS RECOVERING WELL.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 16761710 ↗InjuryMar 14, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT A PATIENT PRESENTED WITH PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16536743 ↗InjuryFeb 14, 2023Failure to Convert Rhythm; Inappropriate or Unexpected Reset; Data Problem; Failure to Convert Rhythm; Inappropriate or Unexpected Reset; Data Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DISCOMFORT AFTER REPEATED SHOCKS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAILED TO RESOLVE THEIR ARRYTHMIA. EXTERNAL DEFIBRILLATION HAD TO BE PERFORMED, WHICH SUBSEQUENTLY CAUSED THE DEVICE TO GO INTO BACK UP MODE. WHILE IN RESET, DEFIBRILLATION THERAPIES WERE NOT AVAILABLE. THE DEVICE WAS SUCCESSFULLY REPROGRAMMED. HOWEVER, DUE TO A DATA ISSUE, PREVIOUS DEVICE RECORDS WERE UNABLE TO BE REVIEWED. THE PATIENT WAS STABLE FOLLOWING PROGRAMMING CHANGES.
Patient problems: Arrhythmia; Discomfort
MAUDE report 16373015 ↗MalfunctionOct 14, 2022Therapy Delivered to Incorrect Body Area; Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Therapy Delivered to Incorrect Body Area; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR MAGNETIC RESONANCE IMAGING (MRI). AFTER THE MRI, THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE AND THERE WAS DIAPHRAGMATIC SIMULATION. HIGH VOLTAGE THERAPY WAS DISABLED IN BACKUP MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: Discomfort
MAUDE report 15608014 ↗InjurySep 18, 2022Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. REVIEW OF THE TRANSMISSION REVEALED A PREMATURE DECLINE IN THE BATTERY LIFE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15443425 ↗MalfunctionFeb 1, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 13416854 ↗InjuryNov 24, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870011 ↗InjuryJul 19, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE'S BATTERY WAS EXHAUSTED AND REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS UNKNOWN WHETHER BATTERY DEPLETION WAS PREMATURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12191678 ↗InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM DEVELOPED AN INFECTION AND EXPERIENCES A SEPTIC SHOCK. THE SYSTEM WAS REMOVED. THE PATIENT WAS STABLE.
Patient problems: Unspecified Infection
MAUDE report 12070948 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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