Assurity MRI™ PM2272Recalls & reported problems
St. Jude Medical, Inc. · DR Pacemaker DDDR · Class 3 · Implant
All models of Assurity MRI (2)
Data updated Oct 18, 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 MRI pacemaker has 16,911 adverse event reports in the FDA database, including 266 deaths and 11,211 injuries. Reports often describe batteries that run down early, pacemakers that cannot be checked or do not respond to a magnet, and devices removed after an alert from the device. There is 1 open recall, started in March 2021, because a manufacturing issue with the epoxy used to build some pacemakers may let moisture in 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
- 16,996
- Deaths reported
- 264
- Injuries reported
- 11,252
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 16,996 adverse event reports that list this exact device (DI 05414734509589), received between Jun 11, 2018 and Sep 30, 2026 — classified as 264 deaths, 11,252 injuries, 5,480 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (1,318 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (P140033); 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 18, 2026.
Reports received per month
Recalls naming this device
- Mar 15, 2021Class IOpen, 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
Device problems
- Adverse Event Without Identified Device or Use Problem9,039
- Over-Sensing1,318
- Failure to Interrogate1,280
- Premature Discharge of Battery1,224
- Defective Device1,140
- Pacing Problem607
- Under-Sensing606
- No Pacing537
Patient problems
- No Clinical Signs, Symptoms or Conditions11,222
- Unspecified Infection1,932
- Insufficient Information1,566
- No Known Impact Or Consequence To Patient762
- Arrhythmia578
- Pocket Erosion503
- Discomfort327
- Dizziness189
Recent adverse event reports
The 25 most recent of 16,996 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955197 ↗MalfunctionSep 30, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955163 ↗MalfunctionSep 30, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955141 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954966 ↗MalfunctionSep 30, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50953547 ↗MalfunctionSep 30, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50952899 ↗InjurySep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952756 ↗InjurySep 30, 2026Migration
It was reported that the patient exhibited Twiddler¿s syndrome causing migration of the pacemaker and dislodgement of the Right Atrial (RA) and Right Ventricular (RV) leads. The dislodgement resulted in diaphragmatic stimulation and patient discomfort. Programming changes were made to address the issue. On (b)(6) 2026, during the procedure, the physician explanted the Right Atrial (RA) lead. A replacement RA lead was installed; however, the lead became dislodged and exhibited noise, high impedance, and low current of injury. RA lead fracture was suspected. This RA lead was not used, and the physician completed the procedure using a different RA lead replacement. Additionally, the RV lead was explanted and replaced during the procedure. The patient was discharged, same day, following the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952390 ↗MalfunctionSep 30, 2026No Apparent Adverse Event
This report is to advise of an event observed during analysis.
Patient problems: Insufficient Information
MAUDE report 50951937 ↗MalfunctionSep 30, 2026No Apparent Adverse Event
This report is to advise of an event observed during analysis
Patient problems: Insufficient Information
MAUDE report 50951666 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced syncope. A capture issue was the suspected cause of the syncope. The device was reprogrammed to resolve the event. The patient was in stable condition.
Patient problems: Syncope/Fainting
MAUDE report 50945571 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the hospital due to infection at the device site. The pacemaker, right atrial lead and right ventricular lead were explanted and replaced. The patient was in stable condition throughout the procedure.
Patient problems: Unspecified Infection
MAUDE report 50942770 ↗MalfunctionSep 30, 2026Intermittent Capture; Under-Sensing
It was reported through a remote transmission that the patient's pacemaker exhibited intermittent loss of capture and ventricular under-sensing. The patient's status was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942020 ↗MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941460 ↗MalfunctionSep 29, 2026Capturing Problem
It was reported that during a patient follow up in-clinic, the device was inappropriately capturing the atrium with ventricular pacing. No intervention was performed. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936098 ↗InjurySep 29, 2026Premature Discharge of Battery
It was reported that the patient's pacemaker exhibited premature battery depletion. The pacemaker was explanted and successfully replaced. The patient was discharged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935177 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented in the clinic with an infection at the implanted device pocket site. The physician explanted the entire system ¿ pacemaker, right ventricular lead and atrial lead due to infection. The patient was in stable condition throughout the procedure.
Patient problems: Unspecified Infection
MAUDE report 50927972 ↗MalfunctionSep 29, 2026Failure to Interrogate
It was reported that the patient presented to the clinic for a scheduled follow-up. During interrogation of the pacemaker, radiofrequency (RF) and inductive telemetry were unavailable. The physician made multiple attempts to interrogate the device but was unsuccessful. No intervention was reported. The patient experienced no adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927865 ↗MalfunctionSep 29, 2026Failure to Capture
It was reported that the patient's pacemaker exhibited loss of atrial capture. The patient's status was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927315 ↗InjurySep 28, 2026Data Problem; Interrogation Problem; Unexpected Mode Switch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926709 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hematoma
MAUDE report 50926276 ↗InjurySep 28, 2026Failure to Capture; Migration
It was reported that the patient's pacemaker system was explanted and replaced with a dual leadless pacemaker due to twiddler's syndrome that was confirmed via X-ray imaging. As a result of the twiddling, loss of capture was observed on the right atrium. The patient was discharged post-procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921398 ↗InjurySep 28, 2026Premature Discharge of Battery
Following the Electronics Performance Indicator (EPI), an alert was received by the clinician and device was explanted. The patient condition was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920544 ↗MalfunctionSep 28, 2026Over-Sensing; Under-Sensing
It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed oversensing noise on the atrial lead. The patient has previous history of atrial fibrillation undersensing which was addressed by reprogramming to the most sensitive setting. Programming changes were performed to address the oversensing noise issue. The patient has been asymptomatic throughout.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918203 ↗InjurySep 28, 2026Failure to Interrogate; Low impedance
It was reported that the patient presented in hospital with bradycardia. Interrogation was attempted, but unable to be performed on the pacemaker (PM) via inductive telemetry. Upon review of previous transmission, it was found that the pacemaker exhibited low pacing impedance. The pacemaker was explanted and replaced. Patient condition was stable throughout.
Patient problems: Arrhythmia
MAUDE report 50916830 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140033. One submission often covers many models, so check the product and lot details in each record.
- Z-1495-2022 · Jun 17, 2022 · Open, ClassifiedMerlin PCS 3650 programmer Model 3330 software
- 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-1531-2021 · Mar 15, 2021 · Open, ClassifiedENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycar
Other Implantable pulse generator, pacemaker (non-CRT) devices
- ACCOLADE™ MRI EL DR L331Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls22 deaths7,984 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)187 deaths7,655 reports
- ACCOLADE™ MRI DR L311Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls59 deaths7,283 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)107 deaths5,971 reports
- ACCOLADE™ DR L301Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls6 deaths2,513 reports
- ACCOLADE™ EL DR L321Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls2 deaths1,906 reports
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 reports
- ESSENTIO™ MRI DR L111Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls9 deaths1,790 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page