QUADRA ALLURE MPRecalls & reported problems across all models

We found 3 models of QUADRA ALLURE MP by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,701 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 28, 2026 — classified as 53 deaths, 627 injuries, 1,021 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (295 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 QUADRA ALLURE MP problems

QUADRA ALLURE MP models

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

• Quadra Allure MP™ PM3562

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  26 deaths1,180 reports
• QUADRA ALLURE MP™ PM3262

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  27 deaths518 reports
• QUADRA ALLURE MP™ PM3160

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  3 reports

Recent QUADRA ALLURE MP adverse event reports

The 15 most recent reports across all models, 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 ↗

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