Unify QuadraRecalls & reported problems across all models

We found 2 models of Unify Quadra by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 199 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Sep 18, 2026 — classified as 13 deaths, 144 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (29 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

Most reported Unify Quadra problems

Unify Quadra models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Unify Quadra™ CD3249-40Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  7 deaths134 reports
• Unify Quadra™ CD3249-40

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  6 deaths65 reports

Recent Unify Quadra adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗

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