Unify Quadra™ CD3249-40QRecalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Unify Quadra is an implantable cardioverter defibrillator. Many of the 135 reports describe the battery running down early, the device resetting or going into backup mode, and infection or wound breakdown at the device site. The reports include 7 deaths and 96 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
- 134
- Deaths reported
- 7
- Injuries reported
- 96
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 05414734504546), received between Jun 22, 2018 and Feb 17, 2026 — classified as 7 deaths, 96 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (20 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 Problem48
- Battery Problem20
- Premature Discharge of Battery14
- Inappropriate or Unexpected Reset13
- Inappropriate/Inadequate Shock/Stimulation13
- Over-Sensing9
- Failure to Interrogate5
- Incorrect Interpretation of Signal5
Patient problems
- No Known Impact Or Consequence To Patient65
- No Clinical Signs, Symptoms or Conditions19
- Unspecified Infection14
- Therapeutic Effects, Unexpected9
- Death6
- No Information6
- Pocket Erosion6
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE BATTERY OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PREMATURELY DEPLETED. FURTHERMORE, THE CAPTURE THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD WERE HIGH. THE PATIENT WAS ASYMPTOMATIC. THE ICD WAS EXPLANTED AND DOWNGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), WHILE THE RV LEAD WAS CAPPED AND THE PATIENT'S PREVIOUS RV LEAD WAS REUSED WITH THE NEWLY IMPLANTED CRT-P. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368869 ↗MalfunctionJan 23, 2026Loose or Intermittent Connection; Connection Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEFT VENTRICULAR (LV) LEAD IMPLANT PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE FAILED TO BE WITHDRAWN FROM THE LV LEAD AND THAT THE LV LEAD BECAME FRACTURED FROM TENSION. IT WAS ALSO FOUND THAT THE SET SCREW OF THE RIGHT VENTRICULAR PORT OF THE ICD FAILED TO BE TIGHTENED AND THE HEADER OF THE ICD FAILED TO ACCEPT THE CONNECTION TO THE LEAD. THE ICD AND LV LEAD WERE NOT IMPLANTED, AND A REPLACEMENT ICD AND LV LEAD WERE IMPLANTED ON (B)(6) 2025. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163865 ↗MalfunctionNov 26, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED AFTER A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. IT WAS NOTED THAT THE ICD WAS NOT PUT INTO MRI MODE PRIOR TO PROCEDURE. THE DEVICE WAS ATTEMPTED TO BE RESET BUT WAS UNSUCCESSFUL. FURTHER INTERVENTION WAS NOT PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660231 ↗InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE FOLLOW-UP CLINIC WITH SIGNS OF INFECTION. THE WOUND AT THE DEVICE POCKET WAS FOUND TO BE ULCERATED. THE DEVICE AND LEADS WERE VISIBLE THROUGH THE SKIN. THE PHYSICIAN EXPLANTED THE ACTIVE SYSTEM ¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICLE (LV) LEADS. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 22606737 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCE ULCERATED AND THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) ERODE THROUGH SKIN. THE ICD AND THE LEADS WERE EXPLANTED DUE TO INFECTION. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 20274467 ↗InjuryJul 25, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP AFTER THE VENTRICULAR TACHYCARDIA (VT) STORM. AN INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REVEALED THAT THE DEVICE ENTERED BACKUP OPERATION AFTER HIGH VOLTAGE THERAPY WAS SUCCESSFULLY DELIVERED DURING VT STORM. THE DEVICE WAS RESTORED VIA PROGRAMMING. THE PATIENT WAS STABLE.
Patient problems: Arrhythmia
MAUDE report 19831091 ↗MalfunctionJun 1, 2024Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
NEW INFORMATION RECEIVED NOTES THE DEVICE DOES NOT SUPPORT MRI EXAMINATION. THE EXAMINATION WAS PERFORMED WITHOUT THE KNOWLEDGE OF THE CARDIOLOGIST. THE DEVICE WAS OPERATING NORMALLY AFTER RESTORING THE SETTINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19442268 ↗InjuryApr 30, 2024Premature Discharge of Battery; Premature Discharge of Battery
RELATED MANUFACTURER REFERENCE NUMBER:2017865-2024-40133. IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION AND THE LEFT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED NO INTERVENTION WAS PERFORMED ON THE LV LEAD. THE PATIENT WAS IN RECOVERING CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19218155 ↗InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 WITH REDNESS AND SWELLING, SYMPTOMATIC OF POCKET INFECTION. DEVICE EXTRACTION WAS PERFORMED ON AN UNKNOWN DATE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 18753488 ↗InjuryNov 20, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP DUE TO MULTIPLE DEVICE DEFIBRILLATION TREATMENTS. IT WAS FOUND THAT THE DEVICE WAS IN BACKUP VVI MODE. A DEVICE RESTORATION WAS PERFORMED SUCCESSFULLY AND REPROGRAMMED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION PRIOR TO, DURING, AND POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18171481 ↗MalfunctionAug 5, 2023Connection Problem; Connection Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. DURING THE PROCEDURE IT WAS OBSERVED THAT THE LEAD WAS UNABLE TO BE CONNECTED TO LEFT VENTRICULAR PORT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17467077 ↗InjuryJul 25, 2023Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-37147. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-37148. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-37150. IT WAS REPORTED A PATIENT PRESENTED WITH A POCKET ULCER WITH SWELLING AND PAIN AT THE POCKET. WHEN THE PATIENT CAME FOR TREATMENT ON (B)(6) 2023, THE PHYSICIAN FOUND THE LEAD WAS EXPOSED AND THE PATIENT HAD AN INFECTION. THEIR SYSTEM WAS EXPLANTED IN A PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEFT VENTRICULAR SET SCREW SLIPPED AND THE SILICONE PAD WAS DAMAGED BEFORE PULLING OUT THE LEAD. POST-PROCEDURE THE PATIENT WAS STABLE.
Patient problems: Discomfort; Pocket Erosion; Unspecified Infection
MAUDE report 17390478 ↗MalfunctionJun 29, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING IMPLANT THAT AN ISSUE REVEALED CONNECTION ISSUE WITH THE LEFT VENTRICULAR PORT ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17233880 ↗InjuryJan 26, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ERODING FROM HIS POCKET. THE ENTIRE SYSTEM WAS EXPLANTED AS A RESULT. THE PATIENT PRESENTED FOR A DEVICE RE-IMPLANT PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE WAS NOT USED AS THE ATRIAL SET SCREW COULD NOT BE TIGHTEN AND A NEW DEVICE WAS IMPLANTED. THE PATIENT CONDITION WAS STABLE.
Patient problems: Erosion
MAUDE report 16250969 ↗DeathJan 13, 2023Failure to Convert Rhythm; Failure to Convert Rhythm
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-01153. IT WAS REPORTED THE PATIENT WAS IN VENTRICULAR TACHYCARDIA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD DELIVERED SHOCKS BUT WERE UNABLE TO CONVERT THE RHYTHM. THE PATIENT RECEIVED EXTERNAL DEFIBRILLATION WHICH FAILED TO CONVERT THE RHYTHM. THE PATIENT DECEASED.
Patient problems: Arrhythmia
MAUDE report 16164992 ↗MalfunctionDec 15, 2022Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED DURING AN IMPLANT PROCEDURE ON (B)(6) 2022 , THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH FAILURE TO INTERROGATE. THE DEVICE WAS EXCHANGED IN THE SAME OPERATION. POST-PROCEDURE THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15992912 ↗InjuryNov 29, 2022Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE REPORTED DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15879737 ↗InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC DUE TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ERODED THROUGH THE ICD POCKET AND THE ICD POCKET WAS DAMAGED. THE ICD POCKET WAS DISCOVERED TO HAVE INFECTION. THE ENTIRE ICD SYSTEM WAS EXPLANTED DUE TO ICD POCKET INFECTION AND EROSION. THE PATIENT'S CONDITION WAS STABLE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 15664523 ↗InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL DUE TO PRESENCE OF DISCHARGE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET. IT WAS NOTED THAT THE ICD WAS ERODED THROUGH THE ICD POCKET AND POCKET INFECTION WAS DISCOVERED. THE ICD WAS EXPLANTED DUE TO ICD POCKET INFECTION AND EROSION. THE PATIENT'S CONDITION WAS STABLE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 15614255 ↗InjurySep 26, 2022Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP WITH THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. 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 15486605 ↗InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-22570, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-22571, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-22572. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN THE CLINIC WITH IMPROPER HEALING AT THE PACEMAKER INCISION SITE AND EXPERIENCING DISCHARGE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD WERE EXPLANTED AND REPLACED DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 15371831 ↗MalfunctionJul 8, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP WITH THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IN BACKUP OPERATION. THE DEVICE WAS SUCCESSFULLY RESTORED WITH THE PROGRAMMED SETTINGS. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14962882 ↗InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO POCKET EROSION. THE ENTIRE PACEMAKER (PM) SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion
MAUDE report 14316590 ↗InjuryNov 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM. UPON EXAMINATION, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACK-UP MODE. INAPPROPRIATE SHOCK WAS ALSO REPORTED. THE CAUSE OF THE BACK-UP MODE IS UNKNOWN. THE ICD WAS SUCCESSFULLY RESTORED, BUT UPON PERFORMING THE CORRECTIVE CHANGES, PRIOR EGMS WERE FOUND TO BE MISSING. THE PATIENT WAS DISCHARGED AND NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783347 ↗InjurySep 13, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW UP. UPON INTERROGATION, IT WAS OBSERVED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD PREMATURE BATTERY DEPLETION AND A BATTERY PERFORMANCE ALERT. FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12461537 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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