Gallant™ CDHFA500BRecalls & reported problems
St. Jude Medical, Inc. · HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV · Class 3 · Implant
Quick summary
This Gallant implantable defibrillator from St. Jude Medical has 25 adverse event reports, with no deaths and 4 injuries. Most reports describe the device picking up extra electrical signals (over-sensing), often fixed by reprogramming; a few mention leads coming loose, infection, or erosion at the implant site. No recalls name this device. Reports rose sharply, from 3 in the earlier 12-month period to 22 in the most recent.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05415067050090), received between Jul 24, 2025 and Sep 29, 2026 — classified as 4 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (21 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-Sensing21
- Adverse Event Without Identified Device or Use Problem2
- High impedance2
- Loose or Intermittent Connection2
- Therapy Delivered to Incorrect Body Area2
- Intermittent Capture1
- Migration1
- Pacing Asynchronously1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Discomfort2
- Insufficient Information2
- Pocket Erosion2
- Unspecified Infection2
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Over-Sensing
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited crosstalk oversensing. Programming changes were performed. The patient's condition remained stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935467 ↗MalfunctionSep 17, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50810515 ↗MalfunctionSep 15, 2026Over-Sensing
It was reported that the patient presented remotely via merlin.net. Review of transmission revealed that the Implantable Cardioverter Defibrillator (ICD) exhibited Far R wave over-sensing. Programming changes were made. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775278 ↗MalfunctionSep 11, 2026Over-Sensing
During a remote follow-up, episodes of Post-Paced T-wave Oversensing (PPTWOS) and Post-sensed T-wave Oversensing (PSTWOS) were observed on the device. Technical Support was contacted and recommended reprogramming to resolved the event. 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 50730927 ↗MalfunctionAug 31, 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 made. No adverse effects were noted and the patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533730 ↗InjuryAug 21, 2026Migration
It was reported that the patient exhibited Twiddler's Syndrome causing the Right Atrial (RA) and Right Ventricular (RV) leads to become dislodged. The RA and RV lead exhibited low impedance and loss of capture. An X-Ray was performed, and dislodgement of the RA and RV lead were confirmed. Additionally, the Implantable Cardioverter Defibrillator (ICD) migrated due to the patient's Twiddler's Syndrome. The physician explanted and replaced the RA and RV lead. During the procedure, a replacement RV lead was not used due to difficulty obtaining capture. On (b)(6) 2026, during the procedure, the physician also repositioned the ICD. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50378219 ↗MalfunctionJun 25, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED CROSSTALK OVERSENSING RESULTED IN PACING INHIBITION. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT'S CONDITION WAS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628263 ↗MalfunctionJun 23, 2026Over-Sensing
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR R-WAVE OVERSENSING AND NOISE. INTERVENTION WAS NOT REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601763 ↗InjuryMay 10, 2026Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH MUSCLE STIMULATION, DISCOMFORT AND EROSION AT DEVICE POCKET. THE GALLANT AND LEFT VENTRICULAR LEAD WERE REPOSITIONED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Discomfort; Pocket Erosion
MAUDE report 25133757 ↗MalfunctionApr 8, 2026Over-Sensing; Under-Sensing
IT WAS REPORTED THAT THE DEVICE DELIVERED APPROPRIATE HIGH VOLTAGE THERAPY THAT WAS NOT ADEQUATE TO TREAT AN EPISODE OF VENTRICULAR TACHYCARDIA. THE PATIENT PASSED AWAY. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820907 ↗MalfunctionMar 31, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED CROSSTALK OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748659 ↗MalfunctionMar 30, 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 24725894 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH POCKET INFECTION. THE PHYSICIAN ELECTED TO EXPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 24614504 ↗MalfunctionFeb 18, 2026Over-Sensing
IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR R WAVE OVER-SENSING. PROGRAMMING CHANGES WERE SUGGESTED BUT NO INTERVENTION WAS REPORTED. PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381625 ↗MalfunctionFeb 17, 2026Over-Sensing
IT WAS REPORTED THAT POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24369989 ↗MalfunctionFeb 11, 2026High impedance
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT PROCEDURE. DURING THE PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE. THIS ICD WAS NOT USED, AND THE PHYSICIAN COMPLETED THE PROCEDURE USING A DIFFERENT ICD. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315023 ↗MalfunctionFeb 10, 2026Over-Sensing; Pacing Asynchronously
DURING AN IN-CLINIC FOLLOW-UP, EPISODES OF POST-PACED T-WAVE OVERSENSING (PPTWOS) AND FUSION WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304102 ↗MalfunctionJan 30, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH POST-PACED T-WAVE OVER-SENSING 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 24228749 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH POCKET EROSION AND REDNESS AT THE DEVICE IMPLANT SITE, DUE TO INFECTION. THE PHYSICIAN ELECTED TO EXPLANT THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 24206909 ↗MalfunctionJan 20, 2026Over-Sensing
NEW INFORMATION RECEIVED INDICATES THAT PROGRAMMING CHANGES WERE MADE. HOWEVER, POST-PACED T-WAVE OVERSENSING (PPTWOS) REOCCURRED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24118393 ↗MalfunctionJan 19, 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 POST-PACED T-WAVE OVERSENSING (PPTWOS). NO INTERVENTION WAS PERFORMED AND THE PATIENT WILL BE FURTHER MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109338 ↗MalfunctionDec 5, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT POST-PACED T-WAVE OVERSENSING (PPTWOS) RESULTING IN PACING INHIBITION WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE DISCUSSED, NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724436 ↗MalfunctionDec 4, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS DISCOVERED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723715 ↗MalfunctionNov 13, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY WITH NOISE NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD. THE NOISE WAS OVER-SENSED AND RESULTED IN PACING INHIBITION. A LEAD EXTRACTION AND FURTHER INTERVENTION WAS PLANNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550900 ↗MalfunctionNov 11, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTATION PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE LEAD COULD NOT BE PROPERLY PLACED IN THE HEADER OF ICD DUE TO A SET SCREW ISSUE. AS A RESULT, THE ICD WAS NOT IMPLANTED AND REPLACED WITH NEW ICD. THE PATIENT'S CONDITION REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23524833 ↗
Other Pulse-generator, single chamber, sensor driven, implantable devices
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.