AllureRecalls & reported problems across all models

We found 2 models of Allure by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 474 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 8 deaths, 199 injuries, 267 malfunctions.

The most frequently reported specific device problem is “Defective Device” (81 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 Allure problems

Allure models

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

• Allure™ PM3222

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths463 reports
• Allure™ PM3120

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  11 reports

Recent Allure adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954833 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced heart failure and complete heart block. It was noted that the implanted pacemaker eroded through the skin. During the device exchange procedure, it was observed that the left ventricular (LV) lead was fractured. The LV lead was capped and the pacemaker was explanted and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Pocket Erosion

  MAUDE report 50942445 ↗
• MalfunctionSep 29, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928360 ↗
• InjurySep 10, 2026Premature Discharge of Battery

  During an in-clinic follow-up, the longevity of the device was shorter than anticipated. Premature battery depletion is suspected, although not confirmed. The device was explanted and replaced to resolve the event. The patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715276 ↗
• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that a remote alert was received, however no electrograms were received. No intervention has been performed. The patient is stable with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659990 ↗
• MalfunctionSep 3, 2026Connection Problem

  During implant, the atrial lead was unable to be securely connected to the device. The device was explanted and replaced to resolve the event and the patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50587186 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the clinic due to a pocket infection. The physician explanted the pacemaker and replaced it with a leadless pacemaker on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50536502 ↗
• MalfunctionAug 24, 2026Pacing Problem

  During an in-clinic follow-up, automatic mode switch (AMS) was observed on the right atrial (RA) lead and device. No intervention has been performed to resolve the event. The patient is currently stable and will continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408180 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with device erosion through the skin at the pacemaker pocket site. The pacemaker, right atrial lead, right ventricular lead, and left ventricular lead were subsequently explanted and replaced. The patient remained in stable condition throughout the procedure.

  Patient problems: Pocket Erosion

  MAUDE report 50339213 ↗
• InjuryAug 17, 2026Insufficient Device Problem Information

  It was reported that the patient presented for a pacemaker exchange procedure. It was noted that a replacement pacemaker was implanted and explanted on the same procedure day due to unknown reason. A new pacemaker was implanted. The patient's status was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268689 ↗
• MalfunctionAug 13, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241583 ↗
• MalfunctionAug 7, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168808 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with a localized pocket infection at the device implantation site. Due to the infection, the physician elected to explant the pacemaker and the right ventricular (RV) lead on (b)(6) 2026. A replacement procedure was subsequently performed on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50153016 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25674343 ↗
• MalfunctionApr 30, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25047524 ↗

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