Gallant™ CDHFA500DRecalls & reported problems
St. Jude Medical, Inc. · HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV · Class 3 · Implant
Quick summary
This Gallant CRT-D is an implanted defibrillator that also paces the heart. Most of the 126 reports describe oversensing, where the device mistakes electrical signals for heartbeats. The reports include 1 death and 18 injuries. Reports rose to 97 in the last 12 months from 29 in the previous 12. 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
- 131
- Deaths reported
- 1
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 05415067050052), received between Apr 28, 2025 and Sep 30, 2026 — classified as 1 death, 21 injuries, 109 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (91 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-Sensing91
- Adverse Event Without Identified Device or Use Problem10
- Loose or Intermittent Connection6
- Failure to Capture5
- Failure to Interrogate4
- Inappropriate/Inadequate Shock/Stimulation4
- Under-Sensing4
- High impedance3
Patient problems
- No Clinical Signs, Symptoms or Conditions116
- Unspecified Infection8
- Arrhythmia5
- Insufficient Information5
- Pocket Erosion2
- Syncope/Fainting2
- Discomfort1
- Dizziness1
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Over-Sensing; Pacing Asynchronously
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955045 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported during remote follow up that the Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing (PPTWOS). The product will continue to be monitored. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949924 ↗InjurySep 29, 2026Failure to Capture; Incorrect Measurement; Inappropriate or Unexpected Reset
It was reported that the patient presented to the emergency room is bradycardia. Transmission revealed that the patient was in complete heart block and had both near syncopal and syncopal events. The patient's Implantable Cardioverter Defibrillator (ICD) had exhibited a failure to capture and had displayed incorrect capture measurements. It was also noted that the ICD was in backup mode. Device programming changes were performed and the patient was stable.
Patient problems: Arrhythmia; Dizziness; Syncope/Fainting
MAUDE report 50938353 ↗InjurySep 18, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831343 ↗InjurySep 16, 2026High impedance
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) was found to have a high pacing impedance. The ICD was explanted and replaced to resolve the issue. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791735 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient presented to clinic with pocket erosion and infection. A small hole was identified in the skin near the incision scar from the implantable cardioverter defibrillator (ICD) implantation. The patient confirmed non-compliance with post-discharge instructions. As a result, the ICD, right ventricular (RV), right ventricular Left Bundle Branch Pacing (RV-LBBP) and right atrial (RA) leads were explanted on (b)(6) 2026. Echocardiography findings indicated no vegetation on the leads. The explanted system was submitted for pathological evaluation related to the infection. The physician did not specify the cause of the infection or indicate whether the event was related to an Abbott product or procedure. The patient was stable throughout the procedure.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 50705334 ↗MalfunctionSep 8, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678145 ↗MalfunctionSep 7, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658481 ↗MalfunctionSep 4, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50622315 ↗MalfunctionSep 2, 2026Pacing Asynchronously; Under-Sensing
Patient problems: Arrhythmia
MAUDE report 50570046 ↗MalfunctionSep 1, 2026Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the patient presented for in clinic follow-up. Device interrogation revealed that the Implantable Cardioverter Defibrillator (ICD) exhibited a marker anomaly and was not pacing at the programmed rate. Programming changes were performed to resolve the issue. The patient condition was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548034 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented in clinic due to an unknown adverse event. The patient's Implantable Cardioverter Defibrillator (ICD), Right Ventricular (RV), Right Atrial (RA), and Left Ventricular (LV) leads were all explanted. There were no allegations of malfunction on the ICD system. The patient had no consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479576 ↗InjuryAug 26, 2026Signal Artifact/Noise; High impedance; Insufficient Device Problem Information
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) was found to have a bad header, resulting in anomalies. The ICD was explanted and successfully replaced. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463994 ↗MalfunctionAug 21, 2026Over-Sensing
It was reported that Post-Paced T-wave Oversensing (PPTWOS) was noted on the Implantable Cardioverter Defibrillator (ICD). No intervention was reported. The patient condition was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50376496 ↗MalfunctionAug 20, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358786 ↗MalfunctionAug 19, 2026Over-Sensing
It was reported that the implantable cardioverter defibrillator exhibited post-paced t-wave oversensing. Further information was requested however, was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50314668 ↗MalfunctionAug 17, 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) stores 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 50279950 ↗MalfunctionAug 13, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240590 ↗InjuryJul 29, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient received inappropriate Anti-Tachycardia Pacing (ATP) therapy due to incorrect interpretation of rhythm. Programming changes were made. The patient was asymptomatic.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075917 ↗MalfunctionJul 9, 2026Over-Sensing
DURING A CLINIC FOLLOW-UP, EPISODES OF POST-PACED T WAVE OVERSENSING WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766953 ↗MalfunctionJun 29, 2026Over-Sensing
IT WAS REPORTED THAT T WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE RECOMMENDED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25653797 ↗MalfunctionJun 26, 2026Intermittent Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. A REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT ATRIAL CAPTURE. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637489 ↗MalfunctionJun 23, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH FAR R OVER-SENSING NOTED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. CORRECTIVE PROGRAMMING CHANGES WERE RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597258 ↗MalfunctionJun 16, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED A REMOTE TRANSMISSION SHOWING NON-SUSTAINED RV OVERSENSING DUE TO POST-PACED T WAVE OVERSENSING. THE PATIENT PRESENTED TO THE CLINIC, AND PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25518915 ↗MalfunctionJun 15, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. A REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNSPECIFIED T-WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25510734 ↗
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.