Assurity MRIRecalls & reported problems across all models

We found 2 models of Assurity MRI by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 17,838 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 309 deaths, 11,598 injuries, 5,931 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (1,377 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Assurity MRI recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Assurity MRI problems

Assurity MRI models

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

• Assurity MRI™ PM2272

  Implantable pulse generator, pacemaker (non-CRT)
  1 recall264 deaths16,996 reports
• Assurity MRI™ PM1272

  Implantable pulse generator, pacemaker (non-CRT)
  1 recall45 deaths842 reports

Recent Assurity MRI adverse event reports

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

• MalfunctionSep 30, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955197 ↗
• MalfunctionSep 30, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955163 ↗
• MalfunctionSep 30, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955141 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954966 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50953547 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50952899 ↗
• InjurySep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952756 ↗
• InjurySep 30, 2026Migration

  It was reported that the patient exhibited Twiddler¿s syndrome causing migration of the pacemaker and dislodgement of the Right Atrial (RA) and Right Ventricular (RV) leads. The dislodgement resulted in diaphragmatic stimulation and patient discomfort. Programming changes were made to address the issue. On (b)(6) 2026, during the procedure, the physician explanted the Right Atrial (RA) lead. A replacement RA lead was installed; however, the lead became dislodged and exhibited noise, high impedance, and low current of injury. RA lead fracture was suspected. This RA lead was not used, and the physician completed the procedure using a different RA lead replacement. Additionally, the RV lead was explanted and replaced during the procedure. The patient was discharged, same day, following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952390 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 50951937 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  This report is to advise of an event observed during analysis

  Patient problems: Insufficient Information

  MAUDE report 50951666 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced syncope. A capture issue was the suspected cause of the syncope. The device was reprogrammed to resolve the event. The patient was in stable condition.

  Patient problems: Syncope/Fainting

  MAUDE report 50945571 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital due to infection at the device site. The pacemaker, right atrial lead and right ventricular lead were explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50942770 ↗
• MalfunctionSep 30, 2026Intermittent Capture; Under-Sensing

  It was reported through a remote transmission that the patient's pacemaker exhibited intermittent loss of capture and ventricular under-sensing. The patient's status was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942020 ↗
• MalfunctionSep 30, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941460 ↗
• MalfunctionSep 29, 2026Capturing Problem

  It was reported that during a patient follow up in-clinic, the device was inappropriately capturing the atrium with ventricular pacing. No intervention was performed. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936098 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Proclaim12 models · 35,038 reports · 17 recalls
• Durata28 models · 19,805 reports
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls
• Fortify Assura8 models · 8,292 reports