QUADRA ALLURE MP™ PM3262Recalls & reported problems

Summary

The FDA's MAUDE database contains 518 adverse event reports that list this exact device (DI 05414734509091), received between Jun 11, 2018 and Aug 17, 2026 — classified as 27 deaths, 183 injuries, 308 malfunctions.

The most frequently reported specific device problem is “Defective Device” (110 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 518 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Under-Sensing

  It was reported that the patient¿s pacemaker exhibited undersensing of the atrial channel in 2023. Programming changes were performed to VVIR mode on 1 May 2023. Subsequently, the pacemaker was explanted on 14 April 2026 because it had reached the Elective Replacement Indicator (ERI). The patient¿s condition was not known.

  Patient problems: Insufficient Information

  MAUDE report 50268646 ↗
• MalfunctionJun 11, 2026Break; Failure to Disconnect

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE EXCHANGE FOR NORMAL BATTERY DEPLETION, THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE REMOVED FROM THE HEADER. THE SET SCREW WAS REMOVED, BUT THE RV LEAD REMAINED STUCK IN THE HEADER. THE PHYSICIAN HAD TO BREAK THE HEADER TO REMOVE THE LEAD. THE DEVICE WAS SUCCESSFULLY REPLACED, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480128 ↗
• MalfunctionMay 11, 2026Signal Artifact/Noise

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137473 ↗
• DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25086781 ↗
• MalfunctionMay 3, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25064113 ↗
• MalfunctionApr 23, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 24974891 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONSTANT DISCOMFORT IN THE POCKET AREA. THE PATIENT¿S PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 24797017 ↗
• InjuryApr 1, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 24757150 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXHIBITED DISCOMFORT WITH THE INTERACTION OF THE SHOULDER WITH THE PACEMAKER (PM). THE POCKET WAS REVISED, THE PM WAS EXPLANTED AND A NEW PM WAS IMPLANTED MORE MEDIALLY. THE PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 24593670 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED AN INFECTION. VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND THE LEFT VENTRICULAR (LV) LEAD. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 24282427 ↗
• MalfunctionJan 21, 2026Failure to Disconnect

  DURING ROUTINE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO REMOVE THE LEAD FROM THE HEADER OF THE DEVICE. THE DEVICE HEADER WAS BROKEN TO RELEASE THE LEAD TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137648 ↗
• MalfunctionDec 5, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT FREQUENT MAGNET RESPONSES WERE LOGGED OVER THE LAST FEW CHECKS. A LARGE NUMBER OF MAGNET RESPONSES HAVE BEEN LOGGED SINCE THE LAST CLEAR ON (B)(6) 2025. THE PATIENT HAD NOT REPORTED ANY SYMPTOMS. IT IS SUSPECTED THAT THE PATIENT HAS A MAGNETIC CLASP ON A MEDICALERT BRACELET. NO INTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733661 ↗
• MalfunctionNov 23, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN NET. UPON REVIEW, THE PACEMAKER EXHIBITED BOTH OVERSENSING AND UNDERSENSING EPISODES. THE UNDERSENSING WAS DUE TO P WAVES OCCURRING DURING THE POST-VENTRICULAR ATRIAL BLANKING (PVAB). THE INTERMITTENT OVERSENSING OF PHYSIOLOGIC SIGNALS IN THE ATRIAL CHANNEL WAS SUSPECTED FOR THE OVERSENSING EPISODES. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627401 ↗
• InjuryNov 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED, PREMATURE BATTERY DEPLETION OF THE DEVICE WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575895 ↗
• MalfunctionNov 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 23535193 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A DEVICE EXCHANGE PROCEDURE DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI), THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) AND A CARDIAC ARREST. EXTERNAL DEFIBRILLATION THERAPY WAS DELIVERED TO THE PATIENT TO TERMINATE THE VF AND CARDIAC ARREST. ADDITIONALLY, RIGHT VENTRICULAR (RV) LEAD INSULATION DAMAGE WAS SUSPECTED, ALTHOUGH NOT CONFIRMED. THE DEVICE WAS EXPLANTED; THE RV LEAD REMAINS IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 22853871 ↗
• MalfunctionAug 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS

  Patient problems: Insufficient Information

  MAUDE report 22831085 ↗
• MalfunctionJul 22, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE DEVICE EXHIBITED UNDERSENSING. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE AT THIS TIME. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564243 ↗
• MalfunctionJul 6, 2025Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, THE PACEMAKER EXHIBITED UNDERSENSING AND LOSS OF CAPTURE. NO INTERVENTION WAS MADE. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22408529 ↗
• InjuryJul 1, 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 CLINIC FOR GENERATOR EXCHANGE PROCEDURE. DURING THE EXAMINATION, IT WAS NOTED THAT THE PACEMAKER WAS AT RISK OF ERODING THROUGH THE IMPLANTED DEVICE POCKET. THE PHYSICIAN EXPLANTED THE PACEMAKER AND REPLACED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pocket Erosion

  MAUDE report 22371815 ↗
• InjuryJun 30, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLD. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367540 ↗
• MalfunctionJun 30, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED A BACKUP VVI MODE. NO INTERVENTION WAS PERFORMED. PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355253 ↗
• InjuryJun 30, 2025Capturing Problem; Capturing Problem

  IT WAS NOTED THAT THE PATIENT'S PACEMAKER AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE PACEMAKER WAS EXPLANTED AND REPLACED; HOWEVER NO INTERVENTION WAS DONE TO THE LV LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355242 ↗
• MalfunctionJun 25, 2025Incorrect Measurement; Interrogation Problem; Incorrect Measurement; Interrogation Problem

  DURING A CLINIC FOLLOW-UP, A DIAGNOSTIC ANOMALY REGARDING THE LONGEVITY OF THE DEVICE WAS OBSERVED DUE TO AN ALLEGED TELEMETRY DISTURBANCE DURING THE INTERROGATION OF THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328325 ↗
• MalfunctionJun 17, 2025Defective Device; Defective Device

  THE PRODUCT WAS RETURNED WITHOUT A COMPLAINT ASSOCIATED TO THE DEVICE AND THERE IS NO ALLEGATION OF A MALFUNCTION FOR THIS PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 22237803 ↗

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-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.