ENDURITY MRIRecalls & reported problems across all models

We found 2 models of ENDURITY MRI by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,632 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 28, 2026 — classified as 24 deaths, 1,095 injuries, 513 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (299 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

ENDURITY 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-1531-2021 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported ENDURITY MRI problems

ENDURITY MRI models

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

• ENDURITY MRI™ DDDR

  Implantable pulse generator, pacemaker (non-CRT)
  1 recall12 deaths1,414 reports
• ENDURITY MRI™ SSIR

  Implantable pulse generator, pacemaker (non-CRT)
  1 recall12 deaths218 reports

Recent ENDURITY MRI adverse event reports

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

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital for a scheduled pacemaker replacement procedure and extraction of the right ventricular (RV) leads. The patient had experienced syncope and dizziness associated with diminishing R-wave amplitudes and elevated capture thresholds related to both the active and previously capped RV leads. Fluoroscopic evaluation confirmed that the active RV lead had become dislodged. During the procedure, the pacemaker and active RV lead were explanted and replaced. The previously capped RV lead was also explanted on (b)(6) 2026. Subsequently, a new leadless pacemaker system was implanted. The patient remained stable throughout the procedure.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 50914714 ↗
• InjurySep 24, 2026Premature Discharge of Battery; Failure to Interrogate; No Pacing

  Patient problems: Arrhythmia

  MAUDE report 50890389 ↗
• MalfunctionSep 17, 2026Unexpected Mode Switch

  It was reported that the device was found to be in backup operation (BVVI). Technical Support was contacted and the device was reprogrammed to resolved the event. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797573 ↗
• MalfunctionSep 17, 2026Loose or Intermittent Connection; Failure to Disconnect; Connection Problem

  It was reported that the patient presented for an implant procedure. During the procedure, insulation breach was noted on the right ventricular (RV) lead. The lead was attempted to be removed, however during removal attempt, the set screw on the pacemaker's header got stripped, preventing the lead from being disconnected and reconnected to the header. The pacemaker and the RV lead were not used, and a new pacemaker and RV lead was implanted. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797356 ↗
• MalfunctionSep 14, 2026Pacing Problem

  It was reported that the patient presented for a Magnetic Resonance Imaging (MRI) procedure. Following the MRI session and device reprogramming, the patient was noted to have a significantly higher heart rate compared to the baseline/pre-procedure rate. The resolution and patient condition was unknown.

  Patient problems: Arrhythmia

  MAUDE report 50749586 ↗
• MalfunctionSep 9, 2026Over-Sensing

  It was reported that far P-wave oversensing was observed on the device. Abbott Technical Support was contacted who recommended reprogramming. No intervention has been performed. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691088 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital for a device follow-up with redness and swelling at the pocket site. Additionally, device interrogation revealed that the right atrial (RA) lead exhibited increased capture threshold resulting in loss of capture and decreased atrial sensing resulting in undersensing. During the lead revision procedure on (b)(6) 2026, chest X-Ray confirmed that the RA lead had dislodged and there were also yellowish-white secretions within the device pocket. The pacemaker, RA lead and the right ventricular lead were explanted, and a new pacemaker system was implanted on the other side due to pocket infection. The physician stated that the infection was unrelated to the device and leads. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50682088 ↗
• MalfunctionSep 3, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596889 ↗
• InjurySep 2, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50575474 ↗
• InjuryAug 26, 2026Failure to Interrogate; Unexpected Mode Switch

  During a follow-up in-clinic, it was observed that the device was in backup mode. Technical Support was contacted and a firmware download was performed. After reprogramming, the device was unable to be interrogated pair with the an inductive transmitter. The device was explanted and replaced to resolve event. The patient was stable with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462257 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50455262 ↗
• MalfunctionAug 26, 2026Incorrect Measurement

  It was reported that patient presented with false elective replacement indicator noted on the patient's pacemaker. Programming changes were made. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50443887 ↗
• MalfunctionAug 24, 2026Unexpected Mode Switch

  During a follow-up in-clinic, the device was found to be in back-up VVI mode. Technical Support was contacted and the device was reprogrammed to resolve the event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410444 ↗
• MalfunctionAug 19, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325169 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient presented in clinic for follow-up with a red incision and purulent drainage from a pocket infection. The pacemaker was explanted. During implant, the helix on the ventricular Leadless Pacemaker (LP) was damaged and a different device was used to complete the procedure. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50257933 ↗

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
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls