EndurityRecalls & reported problems across all models

We found 2 models of Endurity by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 279 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Sep 17, 2026 — classified as 3 deaths, 127 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Defective Device” (28 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 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, 2021Class IOpen, 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 problems

Endurity models

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

• Endurity™ PM2160

  Pulse generator, permanent, implantable
  1 recall2 deaths237 reports
• Endurity™ PM1160

  Pulse generator, permanent, implantable
  1 recall1 death42 reports

Recent Endurity adverse event reports

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

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Pocket Erosion; Unspecified Infection

  MAUDE report 50797165 ↗
• MalfunctionSep 14, 2026No Pacing

  It was reported that the patient presented remotely via Merlin.net. Upon review, the patient experienced episodes of bradycardia and fainting. The physician confirmed that the pacemaker was functioning perfectly; however, the intervention and patient condition were unknown.

  Patient problems: Arrhythmia; Syncope/Fainting

  MAUDE report 50750107 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a post-operative follow-up. It was noted that the patient repeatedly developed pocket infections associated with redness, swelling, and ulceration. The wound remained open, with the pacemaker exposed, despite two debridement procedures. A small portion of heart tissue was observed on the lead. The physician believed that the infection was device and procedure related. The entire system, including the pacemaker, and the right ventricular lead, was explanted and replaced with a leadless pacemaker. The patient remained in stable condition.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 50725406 ↗
• InjurySep 1, 2026No Pacing

  It was reported that the patient was hospitalized due to repeated fainting episodes. It was also noted that the Subsequent 24-hour Holter monitoring revealed pauses lasting more than 10 seconds. The pacemaker was explanted and replaced. The patient was in stable condition.

  Patient problems: Syncope/Fainting

  MAUDE report 50536396 ↗
• MalfunctionJun 4, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PACEMAKER WAS FOUND TO HAVE REVERTED INTO BACKUP AAI MODE DURING CIQ TESTING. THE DEVICE WAS SUBSEQUENTLY RESTORED FROM BACKUP MODE WITH ASSISTANCE FROM TECHNICAL SERVICES (TS). THE PACEMAKER WAS ULTIMATELY NOT USED AND WAS DEACTIVATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402652 ↗
• MalfunctionMay 12, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25152320 ↗
• MalfunctionApr 17, 2026Loose or Intermittent Connection; Failure to Disconnect

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SET-SCREW OF THE PACEMAKER (PM) WAS STRIPPED. THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY LOOSEN THE SET-SCREW TO REMOVE THE LEAD FROM THE HEADER OF THE PM. THE PM WAS EXPLANTED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908859 ↗
• MalfunctionApr 16, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED FAR R OVER-SENSING WITH P-WAVES OCCURRING WITHIN THE REFRACTORY PERIOD. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892778 ↗
• MalfunctionApr 13, 2026Loose or Intermittent Connection; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR REPLACEMENT PROCEDURE DUE TO REACHING THE ELECTIVE REPLACEMENT INDICATOR (ERI). DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO CONNECT THE CHRONIC RIGHT ATRIAL (RA) LEAD TO THE PACEMAKER, AN UNSPECIFIED FITTING ISSUE WAS ENCOUNTERED IN THE PACEMAKER HEADER DURING THE SCREWING PROCESS. THE RA LEAD ALSO COULD NOT BE REMOVED FROM THE PACEMAKER HEADER. AS A RESULT, THE RA LEAD WAS CUT AND CAPPED, AND THE PACEMAKER WAS NOT USED. THE PHYSICIAN ELECTED TO USE A SINGLE-CHAMBER PACEMAKER TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854700 ↗
• MalfunctionFeb 3, 2026Incorrect Measurement

  DURING AN IN CLINIC FOLLOW UP IN (B)(6) 2025 THE DEVICE SHOWED 6 MONTHS OF BATTERY REMAINING. ANOTHER IN CLINIC FOLLOW UP WAS PERFORMED ON (B)(6) 2026 AND SHOWED 11.8 MONTHS OF BATTERY REMAINING. TECHNICAL SUPPORT WAS CONTACTED AND A DIAGNOSTIC ANOMALY WAS SUSPECTED AS THE 11.8 MONTH REMAINING BATTERY ESTIMATION WAS DEEMED CORRECT. FURTHER INVESTIGATION WAS RECOMMENDED BY TECHNICAL SUPPORT. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254089 ↗
• InjuryJan 22, 2026Failure to Interrogate; No Pacing

  IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP. IT WAS NOTED THAT THE PACEMAKER HAD FAILED TO BE INTERROGATED VIA INDUCTIVE TELEMETRY. THERE WAS NO LV OUTPUT, AND PACING COULD NOT BE INDUCED WITH MAGNET APPLICATION. THE PACEMAKER WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157770 ↗
• InjuryDec 29, 2025Failure to Interrogate; No Pacing; Failure to Interrogate; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN CLINIC FOLLOW-UP WITH VENTRICULAR BRADYCARDIA. DEVICE INTERROGATION WAS ATTEMPTED HOWEVER, THE PACEMAKER (PM) FAILED TO BE INTERROGATED. ON (B)(6) 2025, AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED, NOTING THAT THE PM WAS NOT PROVIDING PACING. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE PM. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 23904098 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH REDNESS, SWELLING, DISCHARGE DUE TO INFECTION AND EROSION AT THE DEVICE SITE. THE INFECTION WAS UNCLEAR EITHER IT IS ASSOCIATED WITH ANY ABBOTT PRODUCT AND/OR PROCEDURE. THE PACEMAKER AND RIGHT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23753797 ↗
• MalfunctionNov 21, 2025No Apparent Adverse Event; No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 23623563 ↗
• MalfunctionNov 11, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A DIAGNOSTICS ANOMALY WAS NOTED ON THE PATIENT'S PACEMAKER. ATRIAL FIBRILLATION EPISODES WERE NOT BEING RECORDED AS EXPECTED. NO INTERVENTION WAS PERFORMED. THE PATIENT CONDITION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523110 ↗

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