Quadra Allure MP™ PM3562Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,180 adverse event reports that list this exact device (DI 05414734510097), received between Jul 10, 2018 and Sep 28, 2026 — classified as 26 deaths, 442 injuries, 712 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (234 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 1,180 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926463 ↗
• MalfunctionSep 11, 2026Over-Sensing

  It was reported that the patient presented for a follow-up in clinic. Upon interrogation, the pacemaker exhibited Far R wave oversensing. Programming changes were made. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726560 ↗
• MalfunctionSep 11, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented for a follow-up in clinic. Interrogation revealed that the atrial channel of the pacemaker exhibited far field R-wave over-sensing which resulted in inappropriate mode switching. The inappropriate mode switch caused the pacemaker to override true episodes that were not transmitted. Programming changes were made to the pacemaker to resolve the issue. The patient remained stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725708 ↗
• MalfunctionSep 9, 2026Unexpected Mode Switch

  It was reported that, during procedure preparation, the pacemaker (PM) was observed to be in emergency backup VVI mode. The PM had not been implanted, and no patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684348 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event

  This report is to advise of an event observed during analysis.

  Patient problems: Insufficient Information

  MAUDE report 50681466 ↗
• MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616640 ↗
• MalfunctionSep 3, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50597335 ↗
• MalfunctionSep 2, 2026Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568682 ↗
• InjurySep 1, 2026Premature Discharge of Battery

  It was reported that the patient presented in the clinic for follow up. Upon device interrogation, it was noted that the pacemaker exhibited premature battery depletion. The pacemaker was explanted and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554194 ↗
• MalfunctionAug 31, 2026Unexpected Mode Switch

  It was reported that the pacemaker was found in back-up mode prior to the implant procedure. The device was not implanted. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515946 ↗
• MalfunctionAug 27, 2026Signal Artifact/Noise; No Apparent Adverse Event

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

  MAUDE report 50465550 ↗
• MalfunctionAug 24, 2026Unexpected Mode Switch

  The pacemaker was found in backup mode. The pacemaker was not used. No intervention was performed. There is no patient involvement for this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50401568 ↗
• MalfunctionAug 23, 2026Intermittent Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50395601 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to hospital with infection and skin erosion at device pocket. The information received indicates that the infection was determined not to be associated with any Abbott product or procedure. The pacemaker, right atrial lead, right ventricular lead and left ventricular lead were explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 50337898 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a follow-up clinic due to improper healing at the pacemaker incision site. To address the issue, the physician explanted the entire pacemaker system. The patient was reported to be stable throughout the procedure.

  Patient problems: Wound Dehiscence

  MAUDE report 50335666 ↗
• MalfunctionAug 19, 2026High impedance; Over-Sensing; Capturing Problem

  It was reported through a remote transmission that noise over-sensing and high capture threshold were noted on the patient's pacemaker and the right atrial (RA) lead. Meanwhile, high pacing impedance measurements were noted on the patient's pacemaker, the left ventricular (LV) and the right ventricular (RV) leads from the same remote transmission. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50314716 ↗
• MalfunctionAug 17, 2026Over-Sensing

  It was reported that the patient presented remotely via Merlin.net. Upon review, the right ventricular lead exhibited noise oversensing, which resulted in pacing inhibition. However, it could not be determined whether the oversensing was due to electromagnetic interference (EMI) on the pacemaker channel. No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276229 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an infection and pocket erosion were observed at the device pocket. The physician alleged the infection was not related to the device or a procedure involving the device. The pocket was cleaned and the device was explanted and replaced to resolve the event. The patient was in stable condition and will continue to be monitored.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 50225642 ↗
• MalfunctionAug 12, 2026Therapy Delivered to Incorrect Body Area

  The patient reported experiencing muscle stimulation in the pocket of the device. Additional information was requested but not yet received. The patient is stable.

  Patient problems: Discomfort

  MAUDE report 50221352 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with a large, oozing scab at the device implantation site secondary to an infection. The physician elected to explant the entire pacing system, including the pacemaker, right ventricular (RV), the right atrial (RA), and left ventricular (LV) leads, on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 50205265 ↗
• MalfunctionJul 30, 2026Loose or Intermittent Connection; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50079328 ↗
• InjuryJul 13, 2026Premature Discharge of Battery; Failure to Interrogate; No Pacing

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH A NEAR SYNCOPAL EPISODE. INTERROGATION NOTED A SUSTAINED ARRYTHMIA, LOSS OF PACING ON THE PACEMAKER, AS WELL AS FAILURE TO INTERROGATE AND PREMATURE BATTERY DEPLETION. THE DEVICE4 WAS EXPLANTED AND REPLACED ON (B)(6) 2026. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Arrhythmia; Dizziness

  MAUDE report 25792071 ↗
• MalfunctionJul 6, 2026Signal Artifact/Noise; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP CLINIC VISIT. UPON DEVICE INTERROGATION, NOISE AND AN INACCURATE MEASUREMENT WERE OBSERVED. SPECIFICALLY, A DISCREPANCY WAS NOTED BETWEEN THE CAPCONFIRM THRESHOLD VALUES AND THE MANUAL THRESHOLD TEST RESULTS. NO ACTION WAS TAKEN TO ADDRESS THE ISSUE, AND THE PACEMAKER WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713695 ↗
• InjuryJul 5, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER HAD MIGRATED AND THE RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS WERE ALL DISLODGED AND TWISTED AROUND ONE ANOTHER. FLUOROSCOPY CONFIRMED BOTH THE PACEMAKER MIGRATION AND THE DISLODGEMENT OF ALL THREE LEADS. THE PACEMAKER WAS REPOSITIONED ON (B)(6) 2026 AND THE THREE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713132 ↗
• MalfunctionJun 28, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, THE PACEMAKER DEMONSTRATED FAR-FIELD R-WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648551 ↗

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-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• 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-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.
• 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.