Endurity™ PM1160Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05414734507042), received between Aug 21, 2018 and Sep 17, 2026 — classified as 1 death, 18 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (P880086); 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, 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 ↗
• 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 ↗
• InjuryNov 3, 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 FOR A FOLLOW UP WITH INFECTION AND WOUND DEHISCENCE AT THE DEVICE POCKET. THE INFECTION WAS NOT RELATED TO ABBOTTS' DEVICES. THE PACEMAKER AND THE RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO INFECTION. A NEW PACEMAKER SYSTEM WAS IMPLANTED ON THE OTHER SIDE. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 23459990 ↗
• MalfunctionAug 27, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SYSTEM IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE SET SCREW OF THE PACEMAKER WAS STRIPPED, MAKING THE DEVICE UNUSABLE. THE PACEMAKER WAS NOT USED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902322 ↗
• MalfunctionAug 18, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER'S SET SCREW WAS STRIPPED AND COULD NOT BE USED FOR THE IMPLANTATION. THE PACEMAKER WAS NOT USED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825101 ↗
• InjuryAug 12, 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 HOSPITAL FOR A FOLLOW-UP WITH THE SKIN OF THE DEVICE POCKET APPEARING RED AND EXPERIENCING DISCHARGE DUE TO INFECTION. THE PHYSICIAN EXPLANTED THE WHOLE SYSTEM- THE PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 22780181 ↗
• MalfunctionJun 4, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED DIAGNOSTICS ANOMALY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138502 ↗
• MalfunctionDec 4, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS IN HIGH OUTPUT MODE DUE TO OUT-OF-RANGE MEASUREMENTS. NO CHANGES OR INTERVENTIONS WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840501 ↗
• MalfunctionNov 12, 2024Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING THE PROCEDURE, THE SET SCREW COULD NOT BE FIXED AND THE LEAD COULD NOT BE LOCKED INTO THE PACEMAKER'S HEADER. THE PACEMAKER WAS NOT USED AND REPLACED DURING THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20670391 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH REDNESS, SWELLING AND DISCOMFORT OF THE INCISION SITE DUE TO INFECTION AND POCKET EROSION. THE PACEMAKER WAS EXPLANTED AND REPLACED AND THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort; Pocket Erosion; Unspecified Infection

  MAUDE report 19803843 ↗
• MalfunctionJan 16, 2024Defective Device; Defective Device

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

  Patient problems: Insufficient Information

  MAUDE report 18522946 ↗
• InjuryNov 22, 2023Adverse 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 DUE TO POCKET EROSION. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Pocket Erosion

  MAUDE report 18191327 ↗
• MalfunctionJun 20, 2023Defective Device; Defective Device

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

  Patient problems: Insufficient Information

  MAUDE report 17162880 ↗
• InjuryJun 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED, THE DEVICE LONGEVITY DECREASED RAPIDLY AND TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THEN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125608 ↗
• InjuryOct 24, 2022Adverse 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 DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658693 ↗
• MalfunctionOct 1, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED INCORRECT MEASUREMENTS. IT WAS NOTED THAT IN DECEMBER THE DEVICE INDICATED THAT THE DEVICE HAS A REMAINING CHARGE UP TO ERI OF 33% WITH A BATTERY VOLTAGE OF 2.95V, AND CURRENT OF 17UA. WHEN IN THE PREVIOUS REVIEW, A REMAINING CHARGE FOR ERI OF 95% AND BATTERY BOLTING OF 2.96V WAS INDICATED. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525688 ↗
• InjurySep 29, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO HAVE ENTERED BACKUP VVI (BVVI) MODE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE WAS REPROGRAMMED; HOWEVER, THE DEVICE REVERTED BACK TO BVVI MODE 14 HOURS LATER. THE DEVICE WAS THEN EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502268 ↗
• MalfunctionAug 8, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING A CLINIC FOLLOW-UP, THE DEVICE WAS OBSERVED TO BE IN BACKUP MODE (BVVI) DUE TO A SOFTWARE RELATED RESET. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183688 ↗
• InjuryNov 15, 2021Premature Discharge of Battery; Failure to Interrogate; Capturing Problem; Premature Discharge of Battery; Failure to Interrogate; Capturing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC REPORTING BRADYCARDIA EPISODES. UPON EXAMINATION, THE PATIENT'S PACEMAKER WAS UNABLE TO BE INTERROGATED. AN UNSPECIFIED CAPTURE ISSUE WAS SUSPECTED DUE TO THE PATIENT'S BRADYCARDIA SYMPTOM. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS STABLE THROUGHOUT THE INTERVENTION PROCESS AND NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 12813925 ↗
• MalfunctionSep 30, 2021Defective Device; Defective Device

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

  Patient problems: Insufficient Information

  MAUDE report 12555561 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P880086. 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-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0297-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator