ENDURITY MRI™ SSIRRecalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 05414734509596), received between Jul 2, 2018 and Sep 28, 2026 — classified as 12 deaths, 94 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (25 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 218 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 11, 2026Unexpected Mode Switch

  It was reported that the patient presented for an implant procedure. During the procedure, and prior to connecting the lead to the device, it was noted that the pacemaker was in backup mode. As a result, the pacemaker was not used and was replaced during the same procedure. The patient remained stable throughout the procedure, and no adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205671 ↗
• InjuryJul 27, 2026Failure to Interrogate; No Pacing

  It was reported that the patient presented at the hospital post-implant procedure. The pacemaker exhibited a loss of pacing. The physician attempted to reprogram the device; however, it could not be interrogated. The patient also experienced several prolonged pauses. Consequently, the physician elected to explant and replace the pacemaker. The patient remained in stable condition.

  Patient problems: Arrhythmia

  MAUDE report 50032254 ↗
• MalfunctionMay 13, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP, EXPERIENCING AN INCREASED HEART RATE AND NOT FEELING WELL WHILE WALKING. IT WAS NOTED THAT THE PACEMAKER EXHIBITED A RATE RESPONSE ISSUE. PROGRAMMING CHANGES WERE SUGGESTED; NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 25157281 ↗
• MalfunctionApr 22, 2026Unexpected Mode Switch

  IT WAS REPORTED, THE DEVICE WAS OBSERVED TO BE IN BACK UP MODE. TECHNICAL SUPPORT WAS CONTACTED AND REPROGRAMMING WAS PERFORMED TO RESOLVE THE EVENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958151 ↗
• MalfunctionMar 18, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, WHILE CONNECTING THE LEAD TO THE PACEMAKER, A FAULT WAS IDENTIFIED WITH THE PACEMAKER SET SCREW UPON TIGHTENING. THE PACEMAKER WAS NOT USED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634607 ↗
• MalfunctionMar 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED UNSPECIFIED ISSUE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542577 ↗
• MalfunctionMar 4, 2026Incorrect Measurement

  IT WAS REPORTED THAT AN INCORRECT BATTERY VOLTAGE MEASUREMENT WAS OBSERVED ON THE DEVICE. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513425 ↗
• InjuryMar 4, 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. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509818 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information; No Pacing

  IT WAS REPORTED THAT THE PATIENT, WHO WAS EXPERIENCING BRADYCARDIA, PRESENTED FOR A REPOSITIONING PROCEDURE. DURING THE PROCEDURE, AFTER THE LEAD WAS RECONNECTED TO THE PACEMAKER, IT WAS OBSERVED THAT THE DEVICE FAILED TO DELIVER PACING STIMULATION AND WAS NOT PROVIDING EFFECTIVE PACING OUTPUT, AS CONFIRMED BY ADDITIONAL FUNCTIONAL TESTING. THE PACEMAKER WAS ALSO NOTED TO BE IN SECURITY MODE DURING INTERROGATION. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT¿S CONDITION WAS UNKNOWN.

  Patient problems: Arrhythmia

  MAUDE report 24466330 ↗
• MalfunctionFeb 2, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PACEMAKER WAS FOUND TO BE IN BACKUP VVI MODE DURING DEVICE INTERROGATION AT THE TIME OF CONFIGURATION. THE PACEMAKER WAS NOT USED AND WAS REPLACED, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242534 ↗
• InjuryJan 15, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN CLINIC FOLLOW-UP. DEVICE INTERROGATION REVEALED PREMATURE BATTERY DEPLETION ON THE PACEMAKER (PM) AND LOW OUT-OF-RANGE PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, NO CAPTURE WAS NOTED ON THE RV LEAD. ON (B)(6) 2026, THE PHYSICIAN EXPLANTED AND REPLACED THE PM. THE RV LEAD WAS CAPPED AND REPLACED THAT SAME DAY. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081620 ↗
• MalfunctionJan 14, 2026Failure to Capture

  IT WAS REPORTED DURING THE PROCEDURE, WHILE CONNECTING THE PACEMAKER TO THE LEAD, NO PACING WAS NOTED ON THE PACEMAKER (PM). DESPITE SEVERAL ATTEMPTS, THE PM WAS NOT USED, AND THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITH A DIFFERENT PACEMAKER. THE PATIENT REMAINED STABLE AND CONTINUED PACING NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072756 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED PROPHYLACTICALLY AS IT IS SUBJECT TO THE ASSURITY AND ENDURITY PACEMAKERS HEADER ANOMALY ADVISORY ISSUED BY ABBOTT ON 15 MARCH 2021. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039951 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DEVICE IS SUBJECT TO THE ASSURITY AND ENDURITY PACEMAKERS HEADER ANOMALY ADVISORY ISSUED BY ABBOTT ON 15 MARCH 2021. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23963113 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DEVICE IS SUBJECT TO THE ASSURITY AND ENDURITY PACEMAKERS' HEADER ANOMALY ADVISORY ISSUED BY ABBOTT ON 15 MARCH 2021. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921337 ↗
• MalfunctionDec 24, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE DEVICE ENTERED BACKUP MODE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS RE-PROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888850 ↗
• InjuryDec 22, 2025Premature Discharge of Battery; Material Discolored; Failure to Interrogate; Premature Discharge of Battery; Material Discolored; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS NOT ABLE TO BE INTERROGATED. PREMATURE BATTERY DEPLETION WAS SUSPECTED. DURING THE EXPLANT PROCEDURE, DISCOLORATION WAS VISUALLY NOTED AT THE HEADER OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866279 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822245 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820646 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23806892 ↗

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-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• 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-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.