Assurity™ PM1240Recalls & reported problems
St. Jude Medical, Inc. · SR Pacemaker SSIR · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This St. Jude Medical Assurity pacemaker is an implanted heart-pacing device. Many of the 303 reports describe pacemakers switching to backup mode, batteries running down early, or failing to be checked, and some describe the device being removed. The reports include 19 deaths and 109 injuries. There is 1 open recall, started in March 2021, over moisture that can enter some pacemakers and cause malfunctions.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 306
- Deaths reported
- 20
- Injuries reported
- 108
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 306 adverse event reports that list this exact device (DI 05414734507066), received between Jun 11, 2018 and Sep 23, 2026 — classified as 20 deaths, 108 injuries, 178 malfunctions.
The most frequently reported specific device problem is “Defective Device” (82 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.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem83
- Defective Device82
- Pacemaker Found in Back-Up Mode36
- Premature Discharge of Battery30
- Failure to Interrogate12
- No Apparent Adverse Event11
- Failure to Capture9
- No Pacing8
Patient problems
- Insufficient Information100
- No Clinical Signs, Symptoms or Conditions97
- No Known Impact Or Consequence To Patient42
- Unspecified Infection30
- Death14
- Arrhythmia8
- Discomfort5
- Dizziness5
Recent adverse event reports
The 25 most recent of 306 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Mode Switch
It was reported that the patient presented in clinic for a follow-up. Upon interrogation, the pacemaker was found to be in backup VVI mode. Additionally, electrogram (EGM) data was absent from the rhythm recordings. Device restoration was performed. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869506 ↗DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported via product return that the patient with the pacemaker and Right Ventricular lead implanted passed away due to hypertension, cardiovascular disease, and effusions. Further information was requested but has not yet been received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812176 ↗MalfunctionSep 3, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50595372 ↗MalfunctionSep 3, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50594573 ↗MalfunctionAug 26, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50461337 ↗MalfunctionJul 6, 2026Premature Discharge of Battery
FOLLOWING THE ELECTRONICS PERFORMANCE INDICATOR (EPI), AN ALERT WAS RECEIVED BY THE CLINICIAN AND AWAITING DEVICE EXPLANT. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE. THE PATIENT CONDITION WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725732 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PACEMAKER EXPLANT PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A HIGH PERCENTAGE OF RIGHT VENTRICULAR (RV) PACING (78%), WHICH RAISED SUSPICION OF RV PACING¿INDUCED CARDIOMYOPATHY. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure
MAUDE report 25326045 ↗InjuryMay 11, 2026Premature Discharge of Battery; Failure to Interrogate
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136894 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL WITH MITRAL VALVE VEGETATION DUE TO INFECTION. THE PATIENT'S SINGLE CHAMBER PACEMAKER SYSTEM; PACEMAKER AND RIGHT VENTRICULAR LEAD WAS EXPLANTED. THE PATIENT WAS IN A STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 24761344 ↗MalfunctionMar 17, 2026Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT HAD PRESENTED FOR A FOLLOW-UP AT THE CLINIC. THE PACEMAKER WAS FOUND TO BE IN BACKUP VVI MODE, POSSIBLY DUE TO A SOFTWARE ERROR. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES, AND THE PATIENT WOULD CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24614440 ↗InjuryMar 9, 2026Premature Discharge of Battery
NEW INFORMATION INDICATES THAT THE PACEMAKER WAS EXPLANTED REPLACED ON (B)(6) 2026. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24548347 ↗MalfunctionFeb 27, 2026No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS
Patient problems: Insufficient Information
MAUDE report 24476489 ↗MalfunctionFeb 19, 2026Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WENT INTO BACKUP MODE. NO INTERVENTION WAS PERFORMED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390959 ↗MalfunctionFeb 10, 2026No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 24310195 ↗DeathFeb 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DIED DUE TO CARDIOPULMONARY ARREST. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251964 ↗InjuryJan 20, 2026Premature Discharge of Battery
FOLLOWING THE ELECTRONICS PERFORMANCE INDICATOR (EPI), AN ALERT WAS RECEIVED BY THE CLINICIAN AND DEVICE WAS EXPLANTED. PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE AND WAS ABLE TO BE DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24118266 ↗MalfunctionJan 6, 2026No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 23985516 ↗InjuryDec 23, 2025Premature Discharge of Battery; Premature Discharge of Battery
NEW INFORMATION RECEIVED NOTED DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2026. PATIENT CONDITION WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23881109 ↗InjuryDec 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WAS EXPLANTED AND REPLACED DUE TO EROSION. PATIENT STATUS WAS NOT PROVIDED.
Patient problems: Pocket Erosion
MAUDE report 23861333 ↗MalfunctionDec 8, 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 23744180 ↗InjuryOct 27, 2025Premature Discharge of Battery; Failure to Interrogate; No Pacing; Premature Discharge of Battery; Failure to Interrogate; No Pacing
NEW INFORMATION RECEIVED NOTED DEVICE ALSO EXHIBITED NO MAGNET RESPONSE AND PREMATURE DISCHARGE OF BATTERY.
Patient problems: Dyspnea
MAUDE report 23396617 ↗MalfunctionSep 17, 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 23076303 ↗MalfunctionSep 9, 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 23011964 ↗MalfunctionAug 27, 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 22909034 ↗InjuryAug 7, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS NOTED ON THE PACEMAKER. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739750 ↗
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-1497-2022 · Jun 17, 2022 · Open, ClassifiedMerlin.net model MN5000 Software
- Z-1496-2022 · Jun 17, 2022 · Open, ClassifiedMerlin 2 PCS MER37000 programmer Model MER3400 software
- Z-1495-2022 · Jun 17, 2022 · Open, ClassifiedMerlin PCS 3650 programmer Model 3330 software
- Z-0429-2012 · Sep 23, 2011 · TerminatedImplantable 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 · TerminatedAnthem 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 · TerminatedSt. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
- Z-0297-2007 · Oct 6, 2006 · TerminatedSt. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
- Z-0296-2007 · Oct 6, 2006 · TerminatedSt. 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 · TerminatedPulse Generator
Other Pulse generator, permanent, implantable devices
- Assurity™ PM2240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall84 deaths4,076 reports
- Fortify Assura™ CD2357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable63 deaths3,571 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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