Quadra Allure™ PM3542Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 05414734510080), received between Nov 21, 2018 and Jul 8, 2026 — classified as 17 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Over-Sensing; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED UNSPECIFIED OVER-SENSING RESULTED IN PACING INHIBITION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25757589 ↗
• MalfunctionMay 6, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A CARDIAC RESYNCHRONIZATION THERAPY (CRT) IMPLANT PROCEDURE. DURING THE PROCEDURE, AFTER ALL LEADS WERE POSITIONED AND SECURED IN THE PACEMAKER HEADER, FINAL FLUOROSCOPY REVEALED REDUCED LEAD SLACK AND DISLODGEMENT OF THE LEFT VENTRICULAR (LV) LEAD. LOSS OF CAPTURE OF THE LV LEAD WAS ALSO NOTED. THE LV LEAD WAS SUBSEQUENTLY DISCONNECTED FROM THE PACEMAKER AND REPOSITIONED. WHILE THE PHYSICIAN WAS SECURING THE LV LEAD INTO THE HEADER, THE SET SCREW FELL FROM THE PACEMAKER. AS A RESULT, THE PACEMAKER WAS NOT USED AND WAS REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107510 ↗
• MalfunctionApr 26, 2026Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW-UP. UPON INTERROGATION, THE RIGHT VENTRICLE (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE. THE PHYSICIAN DECIDED TO REPOSITION THE RV LEAD; HOWEVER, THE LEAD WAS FOUND TO BE STUCK IN THE DEVICE HEADER DUE TO THE INABILITY TO LOOSEN THE SET SCREW. AS A RESULT, BOTH THE PACEMAKER AND RV LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993985 ↗
• InjuryFeb 3, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PACEMAKER WAS EXPLANTED AND REPLACED DUE TO EARLY BATTERY DEPLETION. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246847 ↗
• InjuryDec 23, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885215 ↗
• MalfunctionAug 27, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  DURING AN IN-CLINIC FOLLOW-UP, A DEVICE PARAMETER ERROR WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT (TS) WAS CONTACTED AND CONFIRMED THAT THE ERROR MESSAGE WAS DUE TO SOME ERRONEOUS PARAMETER SETTINGS. TS SUGGESTED THAT THE USER NEEDED TO REPROGRAM THE DEVICE'S SETTINGS TO RESOLVE THE EVENT. THE DEVICE WAS THEN REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906364 ↗
• MalfunctionAug 25, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LEFT VENTRICULAR SET SCREW WAS UNABLE TO BE SCREWED INTO THE DEVICE HEADER. THE DEVICE WAS NOT IMPLANTED, AND A NEW DEVICE WAS IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891348 ↗
• MalfunctionAug 25, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT FAR FIELD R-WAVE OVERSENSING AND INAPPROPRIATE MODE SWITCHING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT, HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891079 ↗
• InjuryMay 7, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOLLOW UP. AN INTERROGATION OF THE PULSE GENERATOR FOUND THAT THE BATTERY HAD DEPLETED PREMATURELY. THE PATIENT WAS SCHEDULED FOR REPLACEMENT AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976587 ↗
• MalfunctionApr 17, 2025Loose or Intermittent Connection; Defective Device; Loose or Intermittent Connection; Defective Device

  DURING DEVICE REPLACEMENT FOR NORMAL BATTERY DEPLETION, DAMAGE WAS OBSERVED ON THE DEVICE HEADER OF THE RIGHT ATRIAL PORT. A DIFFERENT DEVICE WAS SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860722 ↗
• MalfunctionFeb 25, 2025Failure to Capture; Over-Sensing; Pacing Problem; Failure to Capture; Over-Sensing; Pacing Problem

  DURING A REMOTE FOLLOW UP, FAR FIELD R- WAVE OVERSENSING. INAPPROPRIATE AUTOMATIC MODE SWITCH AND LOSS OF CAPTURE WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462469 ↗
• MalfunctionNov 20, 2024Failure to Capture; Failure to Capture

  DURING AN INITIAL IMPLANT PROCEDURE, LOSS OF CAPTURE WAS OBSERVED DURING DEVICE CONNECTION. THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED TO RESOLVE THE EVENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738502 ↗
• MalfunctionMar 8, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED FAR-FIELD R WAVE OVERSENSING LEAD TO INAPPROPRIATE AUTOMATIC MODE SWITCH WAS OBSERVED ON THE DEVICE. NO INTERVENTION WAS PERFORMED; 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 18870629 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2024-22381. RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2024-22382. RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2024-22384. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH DISCHARGE AND SWELLING AT THE PACEMAKER IMPLANT SITE, SYMPTOMATIC OF INFECTION. THE PACING SYSTEM WAS EXTRACTED ON (B)(6) 2024. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 18695593 ↗
• InjuryDec 7, 2023Premature Discharge of Battery; Capturing Problem; Premature Discharge of Battery; Capturing Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-00102. IT WAS REPORTED A PATIENT'S PACEMAKER PRESENTED WITH HIGH CAPTURE THRESHOLDS AND PREMATURE BATTERY DEPLETION. THE LEFT VENTRICULAR (LV) LEAD ALSO HAD HIGH CAPTURE THRESHOLDS. THE PACEMAKER AND LV LEAD WERE EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288415 ↗
• MalfunctionOct 30, 2023Difficult to Insert; Difficult to Insert

  DURING IMPLANT, THE ATRIAL LEAD WAS UNABLE TO BE INSERTED INTO THE PACEMAKER'S HEADER. THE EVENT WAS RESOLVED BY EXPLANTING AND REPLACING THE PACEMAKER. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031400 ↗
• MalfunctionSep 7, 2023Incorrect Measurement; Incorrect Measurement

  DURING AN IN CLINIC FOLLOW-UP, INCORRECT MEASUREMENT DUE TO A DIAGNOSTIC ANOMALY WAS SEEN ON THE DEVICE. 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 17703488 ↗
• MalfunctionMay 24, 2023Break; Loose or Intermittent Connection; Failure to Disconnect; Break; Loose or Intermittent Connection; Failure to Disconnect

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-20845. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-20847. IT WAS REPORTED THAT A PATIENT PRESENTED WITH SYNCOPE, WHICH WAS ALLEGED TO BE DUE TO DISLODGEMENT OF THE LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) LEADS. NO ELECTRICAL MALFUNCTION WAS REPORTED. DURING THE PROCEDURE TO ADDRESS THE LEAD DISLODGEMENT, THE PATIENT'S PACEMAKER SET SCREW WAS UNABLE TO ACCEPT THE HEX-WRENCH, WAS DIFFICULT TO LOOSEN FROM THE RV LEAD, AND WAS DAMAGED. THE RIGHT ATRIAL LEAD WAS ALSO UNABLE TO REMOVED FROM THE DEVICE HEADER. NO MALFUNCTION WAS ALLEGED ON THE RIGHT ATRIAL LEAD. THE LV AND RV LEADS WERE SUCCESSFULLY REPOSITIONED ON (B)(6)2023. THE DEVICE WAS REPLACED DURING THE PROCEDURE ON (B)(6)2023. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998242 ↗
• InjuryMay 2, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857360 ↗
• InjuryApr 12, 2023Premature 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 PACEMAKER (PM). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE PM. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726464 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IN CLINIC FOLLOW UP, AN INFECTION OF THE SKIN OF THE DEVICE POCKET WAS NOTED. THE INFECTION WAS CUT AND CLEARED AND THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16561196 ↗
• InjuryMar 1, 2023Premature Discharge of Battery; Premature Discharge of Battery

  RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2023-11531. RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2023-11532. IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION, THE LEFT VENTRICULAR EXHIBITED FAILURE TO CAPTURE, AND THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6)2023. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464934 ↗
• MalfunctionFeb 27, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE SET SCREW WAS UNABLE TO BE LOOSENED RESULTING IN DIFFICULTY DISCONNECTING THE LEAD FROM THE DEVICE. ADDITIONAL FORCE WAS APPLIED AND THE SET SCREW WAS REMOVED FROM THE HEADER, ATTACHED TO THE HEX WRENCH. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16446203 ↗
• MalfunctionJan 11, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED DURING AN IN CLINIC FOLLOW UP THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WILL CONTINUE TO BE MONITORED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138488 ↗
• MalfunctionDec 7, 2022Over-Sensing; Over-Sensing

  DURING REMOTE MONITORING, EPISODES OF FAR-FIELD P-WAVE OVERSENSING RESULTING IN PACING INHIBITION WERE OBSERVED ON THE DEVICE. THE PACEMAKER DEPENDENT PATIENT EXPERIENCED DIZZINESS DUE TO THE PACING INHIBITION. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Dizziness

  MAUDE report 15934020 ↗

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.