Allure™ PM3222Recalls & reported problems

Summary

The FDA's MAUDE database contains 463 adverse event reports that list this exact device (DI 05414734507905), received between Jun 11, 2018 and Sep 30, 2026 — classified as 8 deaths, 190 injuries, 265 malfunctions.

The most frequently reported specific device problem is “Defective Device” (81 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 463 reports, 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 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH INCREASING DRAINAGE COMING OUT FROM THE DEVICE POCKET SITE. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD AND THE LEFT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER ON (B)(6) 2026 DUE TO INFECTION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24962390 ↗
• MalfunctionApr 7, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 24809228 ↗
• MalfunctionApr 2, 2026Failure to Interrogate; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT THE PACEMAKER WAS IN TELEMETRY LOCKOUT. IT WAS ALSO OBSERVED THAT THE PACEMAKER FAILED TO BE INTERROGATED. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772637 ↗
• MalfunctionApr 1, 2026Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. A REVIEW OF THE TRANSMISSION REVEALED THAT THE PATIENT'S PACEMAKER (PM) EXHIBITED OVERSENSING OF ELECTROMAGNETIC INTERFERENCE (EMI) RESULTED IN PACING INHIBITION. NO CHANGES OR INTERVENTIONS WERE REPORTED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761125 ↗
• MalfunctionMar 23, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE SET SCREW FOR THE LEFT VENTRICLE (LV) CHANNEL OF THE DEVICE WAS UNABLE TO BE COMPLETELY TIGHTENED. THE DEVICE REMAINS IMPLANTED WITH THE LV LEAD CONNECTED. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664145 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC WITH RIGHT VENTRICULAR (RV)-ONLY PACING. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2026 WHILE THE RV LEAD REMAINED IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 24635948 ↗
• MalfunctionMar 10, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE ON (B)(6) 2026. DURING PROCEDURE, IT WAS FOUND THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE PM WAS NOT IMPLANTED AND AN ALTERNATE NEAR AT HAND WAS IMPLANTED INSTEAD. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563255 ↗
• MalfunctionMar 10, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 24561267 ↗
• InjuryFeb 26, 2026Premature Discharge of Battery; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE CLINIC WITH SYNCOPE. THEIR PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES.

  Patient problems: Syncope/Fainting

  MAUDE report 24464263 ↗
• MalfunctionFeb 13, 2026No Pacing

  DURING DEVICE REPLACEMENT, THE DEVICE WAS NOT PACING. 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 24333230 ↗

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.