Allure QuadraRecalls & reported problems across all models

We found 2 models of Allure Quadra by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 419 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2018 and May 17, 2026 — classified as 18 deaths, 175 injuries, 226 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (100 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 Allure Quadra problems

Allure Quadra models

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

• Allure Quadra™ PM3242

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  18 deaths391 reports
• Allure Quadra™ PM3140

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

Recent Allure Quadra adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THE PATIENT'S PACEMAKER (PM) HAD PREMATURELY DEPLETED. THE PATIENT WAS ASYMPTOMATIC. THE PM WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196822 ↗
• MalfunctionApr 2, 2026No Apparent Adverse Event

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 24769432 ↗
• MalfunctionFeb 13, 2026Incorrect Measurement

  IT WAS REPORTED THAT A DIAGNOSTIC ANOMALY WAS OBSERVED ON THE DEVICE. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333020 ↗
• MalfunctionJan 12, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT AFTER INSERTING THE LEAD, THE SET SCREW OF THE RIGHT VENTRICULAR PORT AT THE PACEMAKER'S HEADER WAS UNABLE TO BE TIGHTENED. THE PACEMAKER WAS NOT USED, AND A NEW PACEMAKER WAS IMPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032915 ↗
• MalfunctionSep 17, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE ATRIAL LEAD COULD NOT BE CONNECTED TO THE PACEMAKER (PM). THE PHYSICIAN ELECTED TO NOT USED THE PM. FINALLY, THE SAME ATRIAL LEAD WAS CONNECTED TO THE NEW PM SUCCESSFULLY. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070240 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL PACEMAKER IMPLANT PROCEDURE. IT WAS NOTED THAT DURING POCKET SUTURING, THE PATIENT HAD AN ARRYTHMIA WHICH REQUIRED ANTI-TACHYCARDIA PACING TO TERMINATE IT. THE PACEMAKER WAS NOT IMPLANTED, AND THE POCKET WAS REOPENED TO IMPLANT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INSTEAD ON (B)(6) 2025. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 23016939 ↗
• MalfunctionJun 26, 2025Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 22338704 ↗
• MalfunctionJun 25, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PACEMAKER DEPENDENT PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE. IT WAS NOTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) FAILED TO CAPTURE FROM THE TIME OF ITS INITIAL IMPLANT AND HAD NOT BEEN UTILIZED SINCE THEN. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD FAILED TO BE REMOVED FROM THE PACEMAKER HEADER. THE PHYSICIAN USED EXCESSIVE TECHNIQUE TO REMOVE THE RV LEAD AND IT WAS NOTED THAT THE RV LEAD EXHIBITED INSULATION DAMAGE. TO COMPLETE THE PROCEDURE, THE PHYSICIAN CUT, CAPPED AND REPLACED THE RV LEAD DURING THE PROCEDURE ON (B)(6) 2025. THE OLD LV LEAD WAS PLUGGED INTO THE NEW PACEMAKER AND NOT UTILIZED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333662 ↗
• MalfunctionJun 18, 2025Over-Sensing; Failure to Disconnect; No Pacing; Over-Sensing; Failure to Disconnect; No Pacing

  IT WAS REPORTED THAT DURING A DEVICE REPLACEMENT PROCEDURE DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE SET SCREW OF THE DEVICE WAS DIFFICULT TO BE LOOSENED. NOISE RESULTING IN OVERSENSING AND PACING INHIBITION WAS NOTED ON THE RIGHT VENTRICLE CHANNEL WHILE ACTIVELY LOOSENING THE SETSCREW, RESULTING IN THE PATIENT EXPERIENCING ASYSTOLE. LOOSENING OF THE SETSCREW WAS HALTED, DEVICE PACING CONTINUED, AND THE ASYSTOLE WAS TERMINATED. THE PHYSICIAN CONSIDERED THE ASYSTOLE EPISODES TO BE SHORT AND NOT CLINICALLY SIGNIFICANT. LOOSENING OF THE SETSCREW WAS COMPLETED AND THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 22285985 ↗
• InjuryMay 28, 2025Adverse 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 THEIR PACEMAKER ERODING THROUGH THE POCKET. THE PATIENT'S RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS WERE ALL EXPOSED AND VISIBLE THROUGH THE POCKET. THE RA AND RV LEADS WERE EXPLANTED. THE PACEMAKER AND LV LEAD WERE EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: Pocket Erosion

  MAUDE report 22101469 ↗
• MalfunctionMay 8, 2025Failure to Disconnect; Failure to Disconnect

  DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE DISCONNECTED FROM THE DEVICE. THE RV LEAD WAS CUT, CAPPED AND REPLACED DURING THE PROCEDURE TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989681 ↗
• MalfunctionApr 21, 2025Break; Loose or Intermittent Connection; Difficult to Remove; Break; Loose or Intermittent Connection; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED PACEMAKER CHANGEOUT. DURING THE PROCEDURE, THE SET SCREW OF THE PACEMAKER WAS STRIPPED, DIFFICULT TO REMOVE AND BROKE OFF BELOW THE SCREW HEAD. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870939 ↗
• MalfunctionMar 18, 2025Loose or Intermittent Connection; Defective Device; Loose or Intermittent Connection; Defective Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE IMPLANT OF THE PULSE GENERATOR. DURING THE PROCEDURE THE PHYSICIAN ATTEMPTED TO CONNECT THE GENERATOR TO A LEAD WITH A TORQUE WRENCH. HOWEVER, THE WRENCH WAS UNABLE TO ENGAGE THE SET SCREW. THE PROCEDURE WAS COMPLETED WITH USE OF A REPLACEMENT DEVICE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628277 ↗
• InjuryJan 13, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED A BACKUP VVI MODE. THE PATIENT HAD BEEN EXPERIENCING DISCOMFORT. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 21134888 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WOUND DEHISCENCE AND INFECTION. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS DUE TO DUE TO LONG-TERM USE OF ANTICOAGULANTS COMBINED WITH DIABETES. THE ENTIRE PACEMAKER SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21078585 ↗

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