ENDURITY MRI™ DDDRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,414 adverse event reports that list this exact device (DI 05414734509602), received between Jun 12, 2018 and Sep 24, 2026 — classified as 12 deaths, 1,001 injuries, 401 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (274 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-1531-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,414 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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, 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 19, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325169 ↗
• MalfunctionAug 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  It was reported that the patient presented for a follow-up in clinic. Device interrogation revealed unusual sensed markers on telemetry. Further evaluation determined that the markers were caused by telemetry dropout from the pacemaker. No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231768 ↗
• MalfunctionAug 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176828 ↗
• MalfunctionJul 31, 2026Loose or Intermittent Connection; Failure to Disconnect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50107343 ↗
• MalfunctionJul 30, 2026Pacing Problem; Communication or Transmission Problem; Data Problem

  Additional information was received indicating the device was explanted and replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084194 ↗
• MalfunctionJul 27, 2026No Pacing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036639 ↗
• MalfunctionJul 10, 2026No Pacing

  DURING AN IMPLANT PROCEDURE, THERE WAS NO PACING OBSERVED FROM THE DEVICE UPON CONNECTION. A NEW DEVICE WAS USED TO COMPLETE THE IMPLANT PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785837 ↗
• MalfunctionJun 29, 2026Failure to Interrogate; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP IN CLINIC. IT WAS NOTED THAT BACKUP VVI MODE WAS OBSERVED ON THE PACEMAKER. THE BACKUP VVI OCCURRED AFTER THE PATIENT PASSED THROUGH A STRONG MAGNETIC FIELD IN A TRAIN DEPOT. A DEVICE DOWNLOAD WAS COMPLETED SUCCESSFULLY. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS BEFORE AND AFTER THE EVENT AND WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651384 ↗
• MalfunctionJun 3, 2026Unexpected Mode Switch

  DURING IMPLANT PROCEDURE, THE DEVICE WAS INTERROGATED AND WAS FOUND IN BACK UP MODE. THE DEVICE WAS NOT IMPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382166 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  THE DEVICE IS INCLUDED IN THE FIELD ACTION FOR ASSURITY, ENDURITY INHOMOGENEOUS EPOXY MIXING ISSUED BY ABBOTT ON 18 FEB 2025 FOR A SUBSET OF DEVICES DISTRIBUTED AND IMPLANTED OUTSIDE OF THE UNITED STATES. THE PACEMAKER WAS EXPLANTED AND REPLACED PROPHYLACTICALLY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355486 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  THE DEVICE IS INCLUDED IN THE FIELD ACTION FOR ASSURITY, ENDURITY INHOMOGENEOUS EPOXY MIXING ISSUED BY ABBOTT ON 18 FEB 2025 FOR A SUBSET OF DEVICES DISTRIBUTED AND IMPLANTED OUTSIDE OF THE UNITED STATES. THE PACEMAKER WAS SHUT DOWN AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179387 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PACEMAKER PACING RATE WAS TEMPORARY REPROGRAMMED FOR A SURGERY AND AFTER THE OPERATION WAS DONE, THE DEVICE WAS RETURNED BACK TO ORIGINAL MODE. IT WAS ALLEGED BY A PATIENT FAMILY MEMBER THAT THE TEMPORARY CHANGE IN PACING RATE HAD INDUCED ACUTE HEART FAILURE, AGGRAVATED PLEURAL EFFUSION, AND LEAD TO DETERIORATION OF CARDIAC FUNCTION AND MADE THE PATIENT EXTREMELY WEAK. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 25163688 ↗
• DeathMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANT ON (B)(6) 2026, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED HEART FAILURE AND PASSED AWAY THE NEXT DAY (B)(6) 2026. NO ISSUES WERE FOUND DURING OR AFTER SURGERY. THE PHYSICIAN DID NOT CURRENTLY BELIEVE IT WAS AN ISSUE WITH THE SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25137111 ↗
• InjuryMay 3, 2026High impedance; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER EXPERIENCING A FALL. UPON DEVICE INTERROGATION, THE PACEMAKER EXHIBITED HIGH IMPEDANCE AND NO RESPONSE TO MAGNET APPLICATION. THE PACEMAKER WAS REPOSITIONED. THE PATIENT REMAINED STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062769 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED AS IT IS SUBJECT TO THE ASSURITY, ENDURITY INHOMOGENEOUS EPOXY MIXING FIELD SAFETY CORRECTION ACTION WHICH APPLIES TO A SUBSET OF DEVICES DISTRIBUTED AND IMPLANTED OUTSIDE OF THE UNITED STATES. NO MALFUNCTION WAS REPORTED, AND THE PATIENT IS IN STABLE CONDITION WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033389 ↗
• InjuryApr 28, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT FOLLOWING THE ELECTRONICS PERFORMANCE INDICATOR (EPI), AN ALERT WAS RECEIVED BY THE CLINICIAN. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021978 ↗

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-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1530-2021 · Mar 15, 2021 · Open, Classified
  ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.