Assurity™ PM2260Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 05414734507097), received between Jun 12, 2018 and Jun 4, 2026 — classified as 44 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (22 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. 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-1530-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Failure to Disconnect

  IT WAS REPORTED THAT DURING THE DEVICE REPLACEMENT PROCEDURE DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE VENTRICLE LEAD WAS UNABLE TO DISCONNECT FROM THE DEVICE. USING EXCESSIVE FORCE, THE PHYSICIAN BROKE THE HEADER AND THE LEAD WAS ABLE TO BE REMOVED. THE DEVICE WAS EXPLANTED AND REPLACED. THE VENTRICLE LEAD REMAINS IMPLANTED AND IN USE WITH THE REPLACEMENT DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399181 ↗
• MalfunctionJun 1, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH EPISODES OF ARRHYTHMIA. UPON INTERROGATION, THE PACEMAKER EXHIBITED INTERMITTENT UNDERSENSING EPISODES. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 25349076 ↗
• MalfunctionMay 11, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT THE PACEMAKER AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. NOISE WAS NOT REPRODUCIBLE WITH ISOMETRIC HAND MANEUVERS. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145378 ↗
• MalfunctionApr 6, 2026Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE DEVICE CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER WAS ENCAPSULATED IN CALCIFICATION, RESULTING IN DIFFICULTY TO REMOVE THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS FROM THE HEADER OF THE PACEMAKER. SIGNIFICANT FORCE WAS REQUIRED, AND A METAL TOOL WAS USED TO DETACH THE RA LEAD. THIS RESULTED IN DAMAGE TO THE PART OF THE RA LEAD THAT CONNECTS TO THE HEADER. THE DAMAGE WAS IDENTIFIED WHEN THE PHYSICIAN ATTEMPTED TO CONNECT THE RA LEAD TO THE HEADER OF THE NEW PACEMAKER. THE RA LEAD WAS THEN CAPPED ON (B)(6) 2026, AND THE NEW PACEMAKER WAS PROGRAMMED TO VVI MODE. THE OLD PACEMAKER WAS EXPLANTED AND REPLACED SUCCESSFULLY, WHILE THE RV LEAD REMAINED IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795836 ↗
• InjuryJan 22, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR CHANNEL. THE PHYSICIAN ALLEGED THE EVENT WAS RELATED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148376 ↗
• InjuryDec 16, 2025Unexpected Mode Switch; Unexpected Mode Switch

  DURING A CLINIC FOLLOW-UP, THE DEVICE WAS OBSERVED TO BE IN BACKUP (BVVI) MODE DUE TO AN UNKNOWN CAUSE. 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 23819378 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER AND BOTH LOW VOLTAGE LEADS EXHIBITED UNSPECIFIED ANOMALY. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 23711925 ↗
• MalfunctionOct 30, 2025Failure to Disconnect; Failure to Disconnect

  DURING A PLANNED BOX EXCHANGE, IT WAS NOT POSSIBLE TO REMOVE THE LEADS FROM THE HEADER OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429688 ↗
• MalfunctionJul 20, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC. UPON INTERROGATION, THE PACEMAKER AND ATRIAL LEAD EXHIBITED EPISODES OF NOISE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552551 ↗
• MalfunctionJul 7, 2025Difficult to Remove; Failure to Disconnect; Difficult to Remove; Failure to Disconnect

  DURING A SCHEDULED DEVICE GENERATOR CHANGE, IT WAS NOTED THAT THE SETSCREW OF THE PACEMAKER CANNOT BE LOOSENED WHICH LED TO FAILURE TO REMOVE SETSCREW FROM THE PACEMAKER HEADER. BESIDES THAT, THE PHYSICIAN TRIED TO PULL THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD, BUT HE FAILED. HE FAILED TO REMOVE THE LEADS FROM THE PACEMAKER HEADER. THE PACEMAKER, RA LEAD, AND RV LEAD WERE STILL IMPLANTED WITH ANTIBACTERIAL POUCH DUE TO THE PATIENT BEING PACEMAKER DEPENDENT. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409320 ↗
• MalfunctionJul 1, 2025Difficult to Remove; Failure to Disconnect; Difficult to Remove; Failure to Disconnect

  DURING A ROUTINE DEVICE EXCHANGE, THE SET SCREWS OF THE DEVICE WERE DIFFICULT TO LOOSEN RESULTING IN DIFFICULTY REMOVING THE LEAD FROM THE HEADER OF THE DEVICE CAUSING A SIGNIFICANTLY EXTENDED PROCEDURE TIME. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE AND DID NOT EXPERIENCE ANY CONSEQUENCE DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376099 ↗
• InjuryJun 30, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN EXPLANT PROCEDURE. THE PACEMAKER AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367944 ↗
• MalfunctionJun 30, 2025Failure to Disconnect; Failure to Disconnect

  DURING AN ELECTIVE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO REMOVE THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD FROM THE HEADER OF THE DEVICE. THE LEADS WERE REMOVED WITH STRONG FORCE AND A NEW DEVICE WAS USED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364437 ↗
• InjuryJun 19, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AT THE CLINIC. IT WAS NOTED THAT THE PACEMAKER AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. THE PACEMAKER WAS EXPLANTED AND REPLACED. NO INTERVENTION WAS DONE FOR THE RV LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290864 ↗
• MalfunctionMar 24, 2025Failure to Capture; Pacing Asynchronously; Failure to Capture; Pacing Asynchronously

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE PACEMAKER EXHIBITED LOSS OF CAPTURE AND PACEMAKER MEDIATED TACHYCARDIA (PMT). NO INTERVENTION WAS PERFORMED. ASIDE FROM ARRYTHMIA, NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 21677265 ↗
• MalfunctionFeb 26, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTIVE GENERATOR CHANGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE LEADS WERE STUCK TO THE HEADER OF THE PACEMAKER (PM); THE PHYSICIAN DECONSTRUCTED THE HEADER TO REMOVE THE LEADS. THE PM WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471182 ↗
• MalfunctionJan 19, 2025Difficult to Remove; Failure to Disconnect; Difficult to Remove; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED GENERATOR EXCHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) AND THE RIGHT VENTRICULAR (RV) LEADS WERE DIFFICULT TO BE REMOVED FROM THE PACEMAKER'S HEADER AND THE SETSCREW HAD FAILED TO BE DISCONNECTED. THE RA AND RV LEADS WERE DISCONNECTED SUCCESSFULLY, THE PACEMAKER WAS REPLACED, AND THE LEADS WERE CONNECTED TO THE NEW PACEMAKER. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21188202 ↗
• MalfunctionOct 18, 2024Pacing Asynchronously; Under-Sensing; Pacing Asynchronously; Under-Sensing

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481692 ↗
• MalfunctionAug 27, 2024Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH SHORTNESS OF BREATH AND DIZZINESS. OVER-SENSING OF NOISE WAS NOTED ON THE RIGHT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD. THIS RESULTED IN INAPPROPRIATE AUTOMATIC MODE SWITCH NOTED ON THE ATRIAL LEAD. ADDITIONALLY, THE VENTRICULAR LEAD EXHIBITED EXTRACARDIAC STIMULATION AND FAR P OVER-SENSING AND LOSS OF CAPTURE. THIS RESULTED IN PATIENT DISCOMFORT. PREMATURE BATTERY DEPLETION WAS NOTED ON THE DEVICE. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Dizziness; Dyspnea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077742 ↗
• MalfunctionAug 9, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE ATRIAL CHANNEL OF THE PACEMAKER EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). NO CHANGES OR INTERVENTIONS WERE REPORTED; THE PACEMAKER WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954175 ↗
• MalfunctionMay 21, 2024Failure to Interrogate; Interrogation Problem; Failure to Interrogate; Interrogation Problem

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED FAILURE TO INTERROGATE- NO MAGNET RESPONSE. NO INTERVENTION WAS REPORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356864 ↗
• InjuryMay 15, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NOISE ON THE PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19317476 ↗
• InjuryApr 14, 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 A PACEMAKER THAT HAD ERODED THROUGH THE SKIN. THE PATIENT FELT SOMETHING STRANGE AT THE POCKET SITE. THE PACEMAKER WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort; Pocket Erosion

  MAUDE report 19103137 ↗
• MalfunctionApr 4, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED UNDER SENSING THAT SHOULD HAVE CAUSED MODE SWITCH BUT DID NOT OCCUR ON THE PACEMAKER. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047833 ↗
• InjuryDec 19, 2023Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE PACEMAKER EXHIBITED FAR R OVERSENSING WHICH TRIGGERED AN INAPPROPRIATE AUTOMATIC MODE SWITCH. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361413 ↗

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-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