Endurity™ PM2160Recalls & reported problems

Summary

The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 05414734507059), received between Jun 22, 2018 and May 12, 2026 — classified as 2 deaths, 109 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Defective Device” (25 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 237 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryNov 4, 2025No Pacing; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL EXPERIENCING FATIGUE. UPON ADMISSION, THE PATIENT EXPERIENCED SEVERAL OCCURRENCES OF A SLOW HEART RATE ALTHOUGH DEVICE INTERROGATION WAS NORMAL. DURING THE DEVICE UPGRADE PROCEDURE, THE PACEMAKER FAILED TO PROVIDE OUTPUT WHEN THE PHYSICIAN WAS USING THE PLASMA BLADE. VVI PACING MODE WAS PROGRAMMED WITH NOISE REVERSION ENABLED; THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia; Fatigue

  MAUDE report 23460919 ↗
• InjuryOct 27, 2025Premature Discharge of Battery; Failure to Interrogate; Unexpected Mode Switch; Premature Discharge of Battery; Failure to Interrogate; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW UP VIA MERLIN.NET. A REVIEW OF THE TRANSMISSION REVEALED THAT THE PACEMAKER (PM) WAS IN BACKUP OPERATION. THE PATIENT SUBSEQUENTLY REPORTED IN-CLINIC AND THERE WAS NO MAGNET RESPONSE OR INDUCTIVE TELEMETRY OBSERVED FROM THE DEVICE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397315 ↗
• MalfunctionOct 20, 2025Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER HEADER'S SET SCREWS HAD TO BE DRILLED OUT AS THEY WERE STRIPPED. AFTER SUCCESSFULLY REMOVING THE LEADS, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD'S RING SEAL DETACHED AND WAS LEFT STUCK ON THE HEADER PORT. THE RV LEAD REMAINED IMPLANTED, AND A NEW PACEMAKER WAS IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337615 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE PACEMAKER WAS OBSERVED TO HAVE ERODED. IT IS SUSPECTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE PACEMAKER, OR THE PATIENT CONTRACTED THE INFECTION DURING THE INITIAL IMPLANT PROCEDURE. THE PACEMAKER WAS EXPLANTED AND REPLACED AND THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE CAPPED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Hypersensitivity/Allergic reaction; Pocket Erosion; Unspecified Infection

  MAUDE report 23065817 ↗
• MalfunctionSep 9, 2025Difficult to Remove; Difficult to Remove

  DURING A NORMAL BATTERY DEVICE REPLACEMENT, IT WAS DIFFICULT TO REMOVE THE RIGHT VENTRICULAR (RV) LEAD FROM THE HEADER OF THE DEVICE. THE DEVICE WAS THEN EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009193 ↗
• MalfunctionAug 14, 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 THERE WAS NO CLICKING SOUND FROM THE SET SCREW WHEN THE LEAD WAS CONNECTED TO THE PACEMAKER, AND THE CONNECTION APPEARED TO BE LOOSE. THE PACEMAKER WAS NOT USED AND REPLACED DURING THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812588 ↗
• InjuryJul 23, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE CLINIC FOR A FOLLOW-UP AFTER EXPERIENCING A FAINTING EPISODE. EVALUATION REVEALED THAT THE EPISODE WAS DUE TO PREMATURE BATTERY DEPLETION OF THE PATIENT¿S PACEMAKER. ADDITIONALLY, BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED LOW PACING IMPEDANCE. THE PACEMAKER, RA LEAD, AND RV LEAD WERE ALL EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT REMAINED STABLE.

  Patient problems: Syncope/Fainting

  MAUDE report 22576811 ↗
• MalfunctionJul 18, 2025Failure to Disconnect; Failure to Disconnect

  DURING A NORMAL DEVICE EXCHANGE PROCEDURE, THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE UNABLE TO BE REMOVED FROM THE HEADER OF THE DEVICE. THE DEVICE HEADER WAS BROKEN TO RELEASE THE RV AND RA LEADS AND WAS THEN EXPLANTED. A NEW DEVICE WAS CONNECTED TO THE RV AND RA LEADS AND IMPLANTED TO RESOLVE THE EVENT. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546775 ↗
• DeathJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134579 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED IN HOSPITAL EXPERIENCING REDNESS, SWELLING AND FLUCTUANT SENSATION AT POCKET SITE. BLOOD CULTURE WAS DONE AND CONFIRMED THAT PATIENT HAD AN INFECTION. THE PACEMAKER AND LEADS WERE EXPLANTED ON 10 APR 2025 AND REPLACED WITH NEW LEADLESS PACEMAKER ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES AND PATIENT CONDITION WAS STABLE AFTER PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 22088647 ↗
• MalfunctionMay 9, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED PACEMAKER CHANGEOUT. DURING PROCEDURE, THE PACEMAKER AND THE RIGHT ATRIAL (RA) LEAD WAS UNABLE TO BE TO BE SEPARATED. THE PHYSICIAN MADE SEVERAL ATTEMPTS BUT WAS UNSUCCESSFUL. BOTH THE PACEMAKER AND THE LEAD WERE PROGRAMMED OFF AND LEFT IN THE POCKET. A LEADLESS VENTRICULAR PACEMAKER WAS IMPLANTED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991056 ↗
• InjuryMay 4, 2025Adverse 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 THE CLINIC WITH INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED DUE TO THE INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 21957653 ↗
• MalfunctionApr 22, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THERE WAS BLOOD NOTED IN THE PACEMAKER HEADER WHEN THE PHYSICIAN INSERTED THE PACEMAKER IN THE DEVICE POCKET. THE PACEMAKER WAS NOT USED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879156 ↗
• MalfunctionApr 18, 2025Break; Break

  DURING AN UNRELATED PROCEDURE, THE SET SCREW OF THE DEVICE WAS OBSERVED TO BE DAMAGED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868298 ↗
• InjuryApr 17, 2025Failure to Interrogate; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS NOT ABLE TO BE INTERROGATED WITH INDUCTIVE TELEMETRY, HOWEVER THE DEVICE WAS STILL PROVIDING PACING SUPPORT. THE PATIENT WAS INTERROGATED TWO MONTHS PRIOR, AND THE LONGEVITY OF THE DEVICE WAS SIX MONTHS. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858037 ↗
• InjuryMar 11, 2025Premature Discharge of Battery; Premature Discharge of Battery

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-16867. IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD FAILED TO BE SEPARATED FROM THE GUIDEWIRE. THE PHYSICIAN ELECTED TO NOT USE THE LEAD, AND A NEW ONE WAS IMPLANTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574078 ↗
• MalfunctionFeb 18, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING ROUTINE GENERATOR CHANGE PROCEDURE, IT WAS NOTED THAT THE SET SCREW WAS STRIPPED. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401019 ↗

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-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-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-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-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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator