Assurity™ PM1260Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05414734507080), received between Jul 16, 2018 and Jan 21, 2025 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH MSSA BACTEREMIA INFECTION. THE PACEMAKER AND RIGHT VENTRICULAR LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 21194656 ↗
• InjuryMar 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2023-13670. IT WAS REPORTED THAT THE PACEMAKER WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. DURING THE SAME PROCEDURE ON (B)(6) 2023, THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED FOR AN UNKNOWN REASON. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541195 ↗
• MalfunctionMar 2, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT HIGH VENTRICULAR RATE EPISODES WERE OBSERVED TO BE 448 BPM AND 640 BPM, BUT THERE WERE NO EVENTS OF EPISODES ABOVE 290 BPM OBSERVED ON THE HISTOGRAM. A REVIEW CONFIRMED THERE WERE NO VENTRICULAR INTERVALS AS FAST AS THE DEVICE WAS REPORTING. A DISCREPANCY IN THE AVERAGE RATES OF THE EPISODES WAS SUSPECTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475536 ↗
• InjuryJun 24, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS INTERROGATED AND REVEALED THE DEVICE WAS IN BACKUP OPERATION WITH POWER ON RESET (POR). THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVED THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUED TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799459 ↗
• MalfunctionJun 7, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, THE PACEMAKER WAS IN HIGH OUTPUT MODE AS A RESULT OF INTERRUPTED/FAILED AUTO CAPTURE TESTS. NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628641 ↗
• MalfunctionApr 20, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THE PACEMAKER EXHIBITED THE SAME LONGEVITY ESTIMATE AS IT DID IN 2019 AS WELL AS MISSING TREND DATA. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694727 ↗
• MalfunctionDec 10, 2020Loose or Intermittent Connection; Misconnection; Loose or Intermittent Connection; Misconnection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN RIGHT VENTRICULAR (RV) LEAD REPLACEMENT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CASING FOR THE SET SCREW ON THE PACEMAKER FELL OUT ON THE END OF THE WRENCH. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS ASYMPTOMATIC TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10988837 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S RIGHT VENTRICULAR LEAD HAD VEGETATION PRESENT. THE PATIENT WAS STABLE THROUGHOUT THE EXPLANT PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 10291948 ↗
• InjuryJul 10, 2019Insufficient Device Problem Information

  THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON 01 NOVEMBER 2016 UNDER AUTHORIZATION NUMBER E19974033 FOR MANUFACTURER ABBOTT UNDER REGISTRATION NUMBER (B)(4).

  Patient problems: No Information

  MAUDE report 8778812 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information

  THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON 07/02/2019 UNDER AUTHORIZATION NUMBER E19974033 FOR MANUFACTURER ABBOTT UNDER REGISTRATION NUMBER (B)(4).

  Patient problems: No Information

  MAUDE report 8756207 ↗
• MalfunctionDec 19, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE DEVICE WENT INTO BACKUP VVI MODE. TECHNICAL SUPPORT WAS CONTACTED AND ASSISTED WITH REPROGRAMMING THE DEVICE TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8179548 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON OCT 31, 2017 UNDER AUTHORIZATION NUMBER (B)(4) FOR MANUFACTURER ABBOTT UNDER REGISTRATION NUMBER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8042814 ↗
• MalfunctionJul 16, 2018Data Problem; Data Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT, THE PATIENT'S INFORMATION WAS PROGRAMMED ONTO THE PACEMAKER. AFTER A CYBERSECURITY UPGRADE WAS PERFORMED ON THE DEVICE, THE DEVICE WAS INTERROGATED AND NO PATIENT DATA APPEARED. THE DEVICE WAS NOT USED. NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7692258 ↗

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-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-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator