Allure™ PM3120Recalls & reported problems
St. Jude Medical, Inc. · Cardiac Resynchronization Therapy Device, Pulse Generator DDDRV · Class 3 · Implant
All models of Allure (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734507882), received between Aug 13, 2018 and Mar 14, 2024 — classified as 9 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (7 reports).
5 other recalls cover devices cleared under the same FDA submission (P030035); 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.
Reports received per month
Most reported problems
Device problems
- Premature Discharge of Battery7
- Failure to Interrogate2
- Pacemaker Found in Back-Up Mode2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Disconnect1
- Incorrect Measurement1
- No Apparent Adverse Event1
- No Pacing1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient2
- Arrhythmia1
- Discomfort1
- No Information1
- Syncope/Fainting1
- Unspecified Infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2024Premature Discharge of Battery; Failure to Interrogate; No Pacing; Premature Discharge of Battery; Failure to Interrogate; No Pacing
IT WAS REPORTED THAT THE DEVICE WAS NOT PACING AND COULD NOT BE INTERROGATED. THE PATIENT HAD SYNCOPE AND BRADYCARDIA; RESUSCITATION WAS PERFORMED AND THE PATIENT WAS HOSPITALIZED. PREMATURE BATTERY DEPLETION WAS SUSPECTED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.
Patient problems: Arrhythmia; Syncope/Fainting
MAUDE report 18904953 ↗InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2024-33369, 2017865-2024-33370, 2017865-2024-33371. IT WAS REPORTED, THE SYSTEM; DEVICE, RIGHT VENTRICULAR (RV) LEAD, RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD BECAME INFECTED. THE SYSTEM WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: Unspecified Infection
MAUDE report 18772698 ↗InjuryFeb 15, 2024Failure to Disconnect; Failure to Disconnect
RELATED MANUFACTURER REPORT NUMBER: 2017865-2024-22646. IT WAS REPORTED, DURING AN ELECTIVE DEVICE REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE REMOVED FROM THE DEVICE HEADER. THE PROCEDURE WAS STOPPED DUE TO THE INABILITY TO DISCONNECT THE LEAD AND DEVICE. AN ADDITIONAL PROCEDURE WAS PERFORMED AND THE DEVICE AND RV LEAD WERE EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711664 ↗InjuryDec 26, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18395331 ↗InjuryNov 2, 2022Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2022 FOR A FOLLOW-UP. DURING EXAMINATION, IT WAS NOTED THAT THE PACEMAKER COULD NOT BE INTERROGATED AS IT HAD REACHED END OF LIFE (EOL). IT WAS SUSPECTED THAT THE DEVICE HAD PREMATURE DISCHARGE OF BATTERY. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15713188 ↗MalfunctionAug 2, 2022Premature Discharge of Battery; Incorrect Measurement; No Apparent Adverse Event; Premature Discharge of Battery; Incorrect Measurement; No Apparent Adverse Event
IT WAS REPORTED THAT BATTERY DEPLETION WAS SUSPECTED TO BE FASTER THAN ANTICIPATED ON THE PACEMAKER . THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15147878 ↗InjuryOct 25, 2021Premature Discharge of Battery; Premature Discharge of Battery
NEW INFORMATION RECEIVED INDICATED THE PATIENT'S PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2021 WITHOUT ISSUE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12689417 ↗InjurySep 3, 2021Premature Discharge of Battery; Premature Discharge of Battery
NEW INFORMATION NOTED THAT THE PACEMAKER WAS EXPLANTED. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12423965 ↗InjuryFeb 10, 2020Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode
NEW INFORMATION NOTED THE PATIENT WAS UNSTABLE AND THE REASON FOR THIS WAS BECAUSE THE DEVICE WAS IN BACK-UP MODE, THE DEVICE WAS PACING IN VVI MODE WHICH MADE THE PATIENT FEEL UNCOMFORTABLE. THE DEVICE WAS EXPLANTED. PATIENT IS STABLE.
Patient problems: Discomfort; No Known Impact Or Consequence To Patient
MAUDE report 9685494 ↗InjuryNov 12, 2019Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PACEMAKER IMPLANT ON (B)(6) 2016. ON (B)(6) 2019, THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC AND UPON DEVICE INTERROGATION IT WAS NOTED THAT THE ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED. IT WAS SUSPECTED TO HAVE BEEN DRAINED DUE TO PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS STABLE THROUGHOUT THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9310464 ↗MalfunctionAug 13, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode
IT WAS REPORTED THAT WHEN A PATIENT PRESENTED IN CLINIC DURING FOLLOW-UP IN BACKUP VVI. A BACKUP VVI DEVICE STATUS REPORT DID NOT PRINT. A DEVICE IMAGE WAS RECEIVED FOR FURTHER INVESTIGATION. A DEVICE RESTORATION WAS PERFORMED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Information
MAUDE report 7778340 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P030035. One submission often covers many models, so check the product and lot details in each record.
- Z-1496-2022 · Jun 17, 2022 · Open, ClassifiedMerlin 2 PCS MER37000 programmer Model MER3400 software
- Z-1497-2022 · Jun 17, 2022 · Open, ClassifiedMerlin.net model MN5000 Software
- Z-1495-2022 · Jun 17, 2022 · Open, ClassifiedMerlin PCS 3650 programmer Model 3330 software
- 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-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.
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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