Gallant™ CDHFA500TRecalls & reported problems
St. Jude Medical, Inc. · HF Cardiac Resynchronization Therapy Defibrillator · Class 3 · Implant
Quick summary
This St. Jude Medical Gallant cardiac resynchronization defibrillator is an implanted heart device that delivers pacing and shock therapy for heart rhythm problems. The 68 reports mostly describe the device misreading the heart's own signals, picking up extra beats it shouldn't, and in some cases delivering shocks that were not needed; others mention failure to pace or to read out device data. There are 1 death, 13 injuries, and 54 malfunctions reported. No recalls name this device.
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
- 71
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 05415067049520), received between Sep 5, 2024 and Sep 29, 2026 — classified as 1 death, 15 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (39 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-Sensing39
- Adverse Event Without Identified Device or Use Problem6
- Under-Sensing6
- Inappropriate/Inadequate Shock/Stimulation5
- Failure to Capture3
- Failure to Interrogate3
- Incorrect Interpretation of Signal3
- Loose or Intermittent Connection3
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Insufficient Information5
- Unspecified Infection5
- Arrhythmia4
- Discomfort3
- Dizziness1
- Fever1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Deliver Shock/Stimulation
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) failed to deliver shock. No changes or interventions were reported. The patient condition was not known.
Patient problems: Arrhythmia
MAUDE report 50935766 ↗MalfunctionSep 16, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795497 ↗MalfunctionSep 14, 2026Over-Sensing
It was reported that a review of remote transmission showed the device exhibiting non-sustained RV oversensing due to post-paced T-wave oversensing. Programming changes were discussed but not made at this time. No patient symptoms were reported.
Patient problems: Insufficient Information
MAUDE report 50753932 ↗InjurySep 3, 2026Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
It was reported that the patient received inappropriate therapy and presented remotely via merlin.net. Review of transmission revealed that the Implantable Cardioverter Defibrillator (ICD) exhibited under-sensing. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590777 ↗MalfunctionAug 31, 2026Over-Sensing
It was reported that the patient presented in clinic with symptom of presyncope. A device interrogation showed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing. Programming changes were made. The patient had no adverse consequences due to the event.
Patient problems: Dizziness
MAUDE report 50525542 ↗InjuryAug 19, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
It was reported during in clinic follow up that the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate shock due to incorrect interpretation of signal. Programming changes were made. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327555 ↗MalfunctionAug 7, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177858 ↗InjuryAug 3, 2026Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
It was reported that a patient presented with functional under-sensing resulting in inappropriate shock noted on the implantable cardioverter defibrillator. corrective programming changes were recommended. No adverse patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123580 ↗MalfunctionJun 24, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESETEED WITH POST-PACED T-WAVE OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILTOR. AS ONLY ONE INSTANCE WAS NOTED, THE DEVICE WOULD CONTINUE TO BE MONITORED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612655 ↗MalfunctionJun 24, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610028 ↗MalfunctionJun 11, 2026Over-Sensing
IT WAS REPORTED THAT POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON THE DEVICE. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480183 ↗MalfunctionJun 8, 2026Over-Sensing; Pacing Asynchronously
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR-FIELD R-WAVE OVERSENSING AND PACEMAKER MEDIATED TACHYCARDIA. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT ISSUES.
Patient problems: Arrhythmia
MAUDE report 25438318 ↗MalfunctionMay 22, 2026Loose or Intermittent Connection
DURING INITIAL IMPLANT PROCEDURE, IT WAS NOT POSSIBLE TO TIGHTEN THE SET SCREW IN THE HEADER OF THE DEVICE. A NEW DEVICE WAS SELECTED AND IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25254945 ↗MalfunctionMay 21, 2026Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ATRIAL UNDER-SENSING. PROGRAMMING CHANGES WERE DISCUSSED, NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244635 ↗InjuryMay 11, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A PATIENT PRESENTED WITH INAPPROPRIATE SHOCK NOTED DUE TO INCORRECT INTERPRETATION OF SIGNAL SEEN ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PROGRAMMING CHANGES WERE RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137740 ↗MalfunctionMay 8, 2026Over-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR-FIELD R-WAVE OVERSENSING. ATRIAL SENSITIVITY WAS ADJUSTED; HOWEVER, THIS RESULTED IN P-WAVE UNDER-SENSING. FURTHER PROGRAMMING CHANGES WERE DISCUSSED BUT NO ADDITIONAL CHANGES OR INTERVENTIONS WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130760 ↗MalfunctionMay 8, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS) STORED AS NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) EPISODE. PROGRAMMING CHANGES WERE DISCUSSED, NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129999 ↗InjuryMay 6, 2026Failure to Deliver Shock/Stimulation; Incorrect Interpretation of Signal
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ARRHYTHMIA AND PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INCORRECT INTERPRETATION OF TRUE VENTRICULAR TACHYCARDIA AS SUPRAVENTRICULAR TACHYCARDIA (SVT) AND DELAYED THERAPY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Arrhythmia
MAUDE report 25107063 ↗MalfunctionApr 6, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH POST-PACED T-WAVE OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. CORRECTIVE PROGRAMMING CHANGES WERE RECOMMENDED. NO INFORMATION REGARDING ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24795385 ↗MalfunctionMar 24, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. A REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH, OUT-OF-RANGE DEFIBRILLATION IMPEDANCE. A DIAGNOSTIC ANOMALY WAS ALSO NOTED THAT THE DEFIBRILLATION IMPEDANCE OUT OF RANGE ALERT WAS MISSING AND THAT THE LIFETIME RANGES WERE ABSENT FROM TESTING RESULTS. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675123 ↗MalfunctionMar 18, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-SENSED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE, AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634345 ↗MalfunctionMar 17, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH POST-PACED T-WAVE OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE4 CARDIOVERTER DEFIBRILLATOR. NO INFORMATION REGARDING INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24623856 ↗MalfunctionFeb 24, 2026Failure to Capture
IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOSS OF RIGHT VENTRICULAR CAPTURE. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24425192 ↗MalfunctionFeb 5, 2026Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24271896 ↗MalfunctionJan 29, 2026No Apparent Adverse Event; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT PROCEDURE. THE LEFT VENTRICULAR (LV) LEAD WAS NOT SENSING CORRECTLY, AND THIS LV LEAD WAS NOT USED. ADDITIONALLY, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT USED DUE TO AN UNKNOWN REASON. THE PHYSICIAN COMPLETED THE PROCEDURE USING A DIFFERENT ICD AND LV LEAD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215154 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.