Assurity MRI™ PM1272Recalls & reported problems

Summary

The FDA's MAUDE database contains 842 adverse event reports that list this exact device (DI 05414734509572), received between Jun 12, 2018 and Sep 28, 2026 — classified as 45 deaths, 346 injuries, 451 malfunctions.

The most frequently reported specific device problem is “Defective Device” (130 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (P140033); 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.

Recalls naming this device

1. Mar 15, 2021Open, Classified

   Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

   Z-1530-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 842 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Pacing Problem

  It was reported that the patient presented for a remote follow-up. It was noted that the pacemaker exhibited atrial pacing at rates that were not associated with the programmed AAI mode rate of 65 bpm. No intervention was performed, and the pacemaker remained implanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910789 ↗
• MalfunctionSep 17, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50807951 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a remote transmission was received indicating a high ventricular rate episode, ventricular tachycardia with no termination and subsequent autopolarity switch on the pacemaker. The pacemaker does not deliver therapy for arrhythmias such as ventricular tachycardia. The clinician subsequently checked on the patient. It was found that the patient was deceased. There was no complaint of malfunction on the pacemaker/system by the physician.

  Patient problems: Arrhythmia

  MAUDE report 50804903 ↗
• MalfunctionSep 17, 2026Failure to Capture

  It was reported through a remote transmission that the patient's pacemaker had failed to capture. The patient had no adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797296 ↗
• InjurySep 16, 2026Capturing Problem; Migration

  It was reported that a patient presented with dislodgement of the right ventricular lead and migration of the pacemaker due to twiddlers syndrome. This resulted in high capture thresholds on both products. During the revision process, the lead helix was damaged. The system was explanted on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782557 ↗
• MalfunctionSep 14, 2026Unexpected Mode Switch

  Prior to implant. the device was found in backup mode. The device was not implanted and the device was replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755192 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  It was reported that the patient presented to the hospital for a scheduled implant procedure. During the procedure, the left bundle branch area pacing (LBBP) lead helix kept retracting during lead torquing despite using mulitple helix locking tool. Due to the helix mechanism issue, the LBBP lead exhibited inappropriate capture. Additionally, the pacemaker header exhibited a setscrew anomaly. The pacemaker was implanted, however the LBBP lead was removed and replaced. The patient was in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728342 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had an infection due to their pacemaker. The pacemaker was explanted. The patient had no adverse consequences due to the event.

  Patient problems: Unspecified Infection

  MAUDE report 50717529 ↗
• MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566426 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50460862 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50460704 ↗
• MalfunctionAug 17, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 50287465 ↗
• MalfunctionAug 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50248098 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a follow-up clinic visit with a pocket wound infection, fever, and chills. The pocket wound site appeared red and was draining purulent discharge. The physician did not believe that the infection was related to the product or procedure. The physician indicated that the infection was attributed to the patient's immunocompromised condition and delayed medical care. The pacemaker and atrial lead were explanted and replaced with a leadless pacemaker. The patient remained in stable condition throughout the event.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50205178 ↗
• MalfunctionAug 11, 2026Failure to Interrogate

  It was reported that the patient presented for an implant procedure. During the procedure and device interrogation, it was noted that the pacemaker exhibited failure to interrogate- no radiofrequency telemetry. The pacemaker was implanted. No intervention was performed. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204931 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection after device exchange. No intervention or procedure was reported.

  Patient problems: Unspecified Infection

  MAUDE report 50202645 ↗
• MalfunctionJun 22, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PACEMAKER WAS IN BACKUP OPERATION. NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25572922 ↗
• MalfunctionJun 12, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25493773 ↗
• MalfunctionJun 9, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED UNDER-SENSING OF R-WAVE. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452026 ↗
• MalfunctionJun 4, 2026Connection Problem

  THE PATIENT PRESENTED WITH BACTEREMIA, FEVER, AND AN ELEVATED WHITE BLOOD CELL COUNT. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM, INCLUDING THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), THE LEFT VENTRICULAR (LV) LEAD, AND THE RIGHT VENTRICULAR (RV) LEAD. A TEMPORARY PACEMAKER IMPLANTATION WAS ATTEMPTED; HOWEVER, THE TEMPORARY LEAD COULD NOT BE SECURED DUE TO AN ISSUE WITH THE PACEMAKER HEADER. THE PHYSICIAN THEREFORE OPTED TO USE THE PREVIOUS BIVENTRICULAR GENERATOR EXTERNALLY AT THE PATIENT¿S NECK AS A TEMPORARY MEASURE. ON (B)(6) 2026, THE TEMPORARY GENERATOR AND LEAD WERE EXPLANTED. A NEW ICD, RV LEAD, AND RIGHT VENTRICULAR LEFT BUNDLE BRANCH PACING (RVLBP) LEAD WERE SUBSEQUENTLY IMPLANTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387179 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POCKET INFECTION AND WITH NO DEVICE MALFUNCTION. THE PACEMAKER (PM) AND THE RIGHT VENTRICLE (RV) LEAD WERE EXPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 25386666 ↗
• MalfunctionMay 31, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, THE PACEMAKER DEMONSTRATED NOISE. NO INTERVENTION WAS PERFORMED. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345290 ↗
• MalfunctionMay 22, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT PACEMAKER WAS FOUND IN BACKUP VVI MODE DURING THE DEVICE PREPARATION. THE PACEMAKER WAS NOT USED. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252037 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SKIN DISCOLORATION AROUND THE DEVICE IMPLANTATION SITE DUE TO AN INFECTION. THE PHYSICIAN DID NOT SPECIFY THE CAUSE OF THE INFECTION OR WHETHER IT WAS RELATED TO AN ABBOTT PRODUCT OR PROCEDURE. THE PACEMAKER SYSTEM WAS EXPLANTED, AND THE PATIENT WAS RECOVERING POST-PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 25250478 ↗
• MalfunctionMay 19, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED FAR FIELD R-WAVE OVER-SENSING. NO INTERVENTIONS OR CHANGES WERE REPORTED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25225202 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140033. 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-1531-2021 · Mar 15, 2021 · Open, Classified
  ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber brady