Allure Quadra™ PM3242Recalls & reported problems
St. Jude Medical, Inc. · RF CRT Cardiac Resynchronization Therapy Pacemaker DDDRV · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Allure Quadra pacemaker has 391 reports in the FDA database, with 154 injuries and 18 deaths. Many reports describe the battery running down early, the device switching to back-up mode, incorrect readings, and electrical noise being picked up as heartbeats. Some describe difficulty removing old leads during replacement surgery. 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
- 391
- Deaths reported
- 18
- Injuries reported
- 154
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 391 adverse event reports that list this exact device (DI 05414734507912), received between Jun 20, 2018 and May 17, 2026 — classified as 18 deaths, 154 injuries, 219 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (93 reports).
5 other recalls cover devices cleared under the same FDA submission (P030035); they may or may not involve this specific model.
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
- Premature Discharge of Battery93
- Adverse Event Without Identified Device or Use Problem54
- Defective Device50
- Pacemaker Found in Back-Up Mode35
- Incorrect Measurement34
- Over-Sensing30
- Failure to Disconnect25
- Failure to Interrogate14
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- No Known Impact Or Consequence To Patient92
- Insufficient Information52
- Unspecified Infection26
- No Consequences Or Impact To Patient19
- Death15
- Arrhythmia8
- Discomfort7
Recent adverse event reports
The 25 most recent of 391 reports, 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 ↗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 ↗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 ↗InjuryNov 27, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing
RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2024-71105, 2017865-2024-71106, AND 2017865-2024-71107. IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC VIA MERLIN.NET TRANSMISSION. TRANSMISSIONS REVEALED THAT THE PACEMAKER, RIGHT ATRIAL LEAD AND LEFT VENTRICULAR LEAD EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI). THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE OVERSENSING RESULTING PACING INHIBITION. NO INTERVENTION AND PATIENT CONSEQUENCES WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793601 ↗MalfunctionNov 1, 2024Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 20589555 ↗MalfunctionOct 7, 2024Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A DEVICE CHANGE OUT PROCEDURE. DURING THE PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS STUCK IN THE HEADER AND WAS UNABLE TO BE REMOVED. UPON FURTHER INTERROGATION, IT WAS NOTED THAT THE RV LEAD EXHIBITED FAILURE TO CAPTURE, LOW PACING IMPEDANCE, AND THE INSULATION WAS DAMAGED. THE RV LEAD WAS CAPPED, AND THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20380733 ↗MalfunctionJun 17, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING ROUTINE GENERATOR EXCHANGE THAT THE PATIENT NEEDED EXTERNAL DEFIBRILLATION AND THE PHYSICIAN WONDERED IF THE PACEMAKER WAS RESPONSIBLE FOR THE ARRHYTHMIA. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACED THE PACEMAKER. THE PATIENT WAS IN UNSTABLE CONDITION.
Patient problems: Arrhythmia
MAUDE report 19554744 ↗MalfunctionMar 15, 2024Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED VIA RADIOFREQUENCY TELEMETRY. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS UPGRADED AND REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18916296 ↗MalfunctionFeb 19, 2024Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 18731528 ↗InjuryJan 2, 2024Premature Discharge of Battery; No Pacing; Interrogation Problem; Premature Discharge of Battery; No Pacing; Interrogation Problem
IT WAS REPORTED A PATIENT'S PACEMAKER PRESENTED WITH A TRANSMISSION PROBLEM VIA MERLIN.NET. DURING INITIALIZATION OF THE PROGRAMMER SESSION, THE PATIENT EXPERIENCED SYNCOPE WITH LOSS OF PACING. THERE WAS ALSO AN ALLEGATION OF PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. POST-PROCEDURE THE PATIENT STATUS WAS UNKNOWN.
Patient problems: Syncope/Fainting
MAUDE report 18432140 ↗InjuryDec 18, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PACEMAKER THAT WAS EXHIBITING PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED, AND NEW PACEMAKER WAS IMPLANTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18352626 ↗MalfunctionNov 27, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 18212922 ↗InjuryNov 22, 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 CLINIC DUE TO POCKET EROSION. THE PATIENT WAS GIVEN ANTIBIOTICS. THE ENTIRE RIGHT VENTRICULAR, LEFT VENTRICULAR, AND ATRIAL LEADS WERE EXPLANTED AND REPLACED BY THE PHYSICIAN. THE PACEMAKER WAS REPOSTIONED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion
MAUDE report 18190400 ↗MalfunctionNov 1, 2023Loose or Intermittent Connection; Difficult to Remove; Loose or Intermittent Connection; Difficult to Remove
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4) IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED IMPLANT PROCEDURE. DURING PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND DIFFICULT TO BE REMOVED FROM THE PACEMAKER HEADER. THE RV LEAD WAS REMOVED USING ANOTHER HEX WRENCH COMPATIBLE TO THE PACEMAKER HEADER SETSCREW WHILE USING SILICON OIL TO DISCONNECT THE RV LEAD PIN. THE PACEMAKER WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE RV LEAD WAS CONNECTED TO THE NEW PACEMAKER AND WAS FOUND TO FUNCTION AS INTENDED. PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18051084 ↗InjuryOct 17, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT PATIENT PRESENTED FOR ROUTINE GENERATOR CHANGE PROCEDURE. DURING PROCEDURE IT WAS FOUND THAT PATIENT'S ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WAS NOT ABLE TO DISENGAGE FROM DEVICE HEADER IT WAS FURTHER NOTED THAT SET SCREWS OF ATRIAL AND RIGHT VENTRICULAR PORT WERE STRIPPED. THE DEVICE WAS REMAINED IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17951315 ↗DeathSep 26, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode
IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO AN UNKNOWN CAUSE. UPON INTERROGATION, THE DEVICE WAS OBSERVED TO BE IN BACKUP (BVVI) MODE. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17818159 ↗InjurySep 13, 2023Premature Discharge of Battery; Failure to Capture; Failure to Interrogate; Premature Discharge of Battery; Failure to Capture; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. IN CLINIC, THE PACEMAKER PRESENTED WITH LOSS OF CAPTURE, FAILURE TO INTERROGATE, AND NO MAGNET RESPONSE. PREVIOUS INTERROGATION NOTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION AND IT WAS NOTED THAT THE PATIENT FELT FATIGUE SINCE (B)(6) OF 2023. THE REPORTED DEVICE WAS EXPLANTED. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: Fatigue
MAUDE report 17737283 ↗InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-42543. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A SYSTEMIC INFECTION. THE PHYSICIAN EXPLANTED THE ENTIRE PACEMAKER SYSTEM TO RESOLVE THE ISSUE. THE PATIENT EXPERIENCED NO CONSEQUENCES.
Patient problems: Unspecified Infection
MAUDE report 17709257 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P030035. One submission often covers many models, so check the product and lot details in each record.
- Z-1497-2022 · Jun 17, 2022 · Open, ClassifiedMerlin.net model MN5000 Software
- Z-1496-2022 · Jun 17, 2022 · Open, ClassifiedMerlin 2 PCS MER37000 programmer Model MER3400 software
- Z-1495-2022 · Jun 17, 2022 · Open, ClassifiedMerlin PCS 3650 programmer Model 3330 software
- Z-0429-2012 · Sep 23, 2011 · TerminatedImplantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
- Z-0430-2012 · Sep 23, 2011 · TerminatedAnthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
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.
How reports and recalls are matched · Editorial policy · Report an error on this page