Gallant™ CDVRA500TRecalls & reported problems
St. Jude Medical, Inc. · VR Implantable Cardioverter Defibrillator · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067049421), received between Aug 14, 2024 and Sep 16, 2026 — classified as 3 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (4 reports).
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
Most reported problems
Device problems
- Over-Sensing4
- Failure to Interrogate2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Disconnect1
- Inappropriate or Unexpected Reset1
- Inappropriate/Inadequate Shock/Stimulation1
- Incorrect Interpretation of Signal1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792825 ↗InjuryAug 7, 2026Pacing Problem
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited low pacing output. The physician elected to explant and replace the ICD. The patient condition was not known.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181236 ↗MalfunctionAug 6, 2026Failure to Disconnect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50156944 ↗MalfunctionJan 16, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED EPISODES OF MYOPOTENTIALS OVERSENSING. THE ICD WAS REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096736 ↗MalfunctionOct 16, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH VENTRICULAR OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INFORMATION REGARDING INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 23315964 ↗InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH SWELLING AT THE DEVICE POCKET DUE TO INFECTION. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND THE RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 22892299 ↗MalfunctionAug 20, 2025Over-Sensing; Over-Sensing
NEW INFORMATION NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-SENSED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22855204 ↗MalfunctionAug 8, 2025Incorrect Measurement; Inappropriate or Unexpected Reset; Incorrect Measurement; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT A PATIENT PRESENTED WITH DEVICE RESET AND A DIAGNOSTIC ISSUE NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22758095 ↗InjuryJul 16, 2025Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY DELIVERED FOR SUPRAVENTRICULAR TACHYCARDIA ON THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO CHANGES OR INTERVENTIONS WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22519871 ↗MalfunctionDec 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-73651. IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO TIGHTEN THE DEVICE SET SCREW FOR TWO ATTEMPTED DEVICES. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21044795 ↗MalfunctionAug 28, 2024Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED BLUETOOTH TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20085230 ↗MalfunctionAug 14, 2024Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR P WAVE OVERSENSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19982612 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 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
- Page last rebuilt: Oct 13, 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