Gallant™ CDVRA500QRecalls & reported problems
St. Jude Medical, Inc. · VR Implantable Cardioverter Defibrillator VVEV VVIR · Class 3 · Implant
All models of Gallant (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This St. Jude Medical Gallant defibrillator is implanted in the chest to treat abnormal heart rhythms. Of its 1,142 reports, 22 describe a patient death, 413 describe injuries and 707 describe malfunctions. Most reports describe the device failing to be checked remotely, unexpected shocks, unexpected resets and noise read as heartbeats. 2 open recalls cite Bluetooth malfunctions linked to a component problem, which can block remote monitoring and shorten battery life.
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
- 1,164
- Deaths reported
- 22
- Injuries reported
- 414
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,164 adverse event reports that list this exact device (DI 05415067031990), received between Sep 4, 2020 and Sep 29, 2026 — classified as 22 deaths, 414 injuries, 728 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (332 reports).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- Aug 16, 2023Open, Classified
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Z-2614-2023 · Root cause: Component design/selection · Recall details · FDA record ↗
- Mar 10, 2022Open, Classified
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Z-0989-2022 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Interrogate332
- Inappropriate/Inadequate Shock/Stimulation181
- Adverse Event Without Identified Device or Use Problem177
- Inappropriate or Unexpected Reset137
- Over-Sensing134
- Incorrect Interpretation of Signal121
- Environmental Compatibility Problem82
- Under-Sensing48
Patient problems
- No Clinical Signs, Symptoms or Conditions888
- Unspecified Infection144
- Arrhythmia61
- Discomfort44
- Insufficient Information40
- Pocket Erosion25
- Wound Dehiscence18
- Syncope/Fainting10
Recent adverse event reports
The 25 most recent of 1,164 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 oversensing due to dislodgment on the Right Ventricular (RV) lead. No changes or interventions were reported. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935410 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the clinic with an infection. The physician explanted the entire pacing system, consisting of the implantable cardioverter-defibrillator (ICD) and right ventricular (RV) lead, and replaced it with a leadless pacemaker on (b)(6) 2026. The patient remained in stable condition.
Patient problems: Unspecified Infection
MAUDE report 50928381 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the hospital with an infection and skin erosion at the device pocket site. The infection was not associated with any Abbott product and/or procedure. No erosion or lead vegetation was reported. The gallant and right ventricular lead were explanted. The patient was in stable condition throughout the procedure.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 50911028 ↗MalfunctionSep 28, 2026Failure 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 50910796 ↗MalfunctionSep 25, 2026Failure to Interrogate
It was reported that the implantable cardioverter defibrillator (ICD) exhibited Bluetooth (BLE) telemetry loss. No intervention was performed. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897623 ↗MalfunctionSep 24, 2026Failure 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 50886488 ↗MalfunctionSep 24, 2026Loose or Intermittent Connection
During an unrelated revision procedure of the right ventricular (RV) lead, the RV set screw was not able to engage with the RV lead when inserted into the header of the device. The device was explanted and replaced to resolve this event. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884023 ↗MalfunctionSep 18, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator exhibited loss of Bluetooth telemetry. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821064 ↗MalfunctionSep 18, 2026Failure to Interrogate
It was reported that the implantable cardioverter defibrillator (ICD) exhibited Bluetooth (BLE) telemetry loss. No intervention was performed. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818801 ↗MalfunctionSep 17, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator exhibited loss of Bluetooth telemetry. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806056 ↗MalfunctionSep 17, 2026Failure to Interrogate
It was reported that the implantable cardioverter defibrillator (ICD) exhibited Bluetooth (BLE) telemetry loss. No intervention was performed. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803990 ↗MalfunctionSep 17, 2026Failure to Interrogate
It was reported that the implantable cardioverter defibrillator (ICD) exhibited Bluetooth (BLE) telemetry loss. No intervention was performed. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803861 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50796931 ↗InjurySep 16, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
During a remote follow-up, VF Therapy Assurance (VFTA) was activated, and shock was delivered due to an incorrect interpretation of signals. No intervention has been performed. The patient was stable and will continue to be monitored.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794066 ↗MalfunctionSep 16, 2026Failure to Convert Rhythm
It was reported that the patient had experienced Ventricular Tachycardia (VT), the device delivered high voltage therapy, however the shock did not initially convert the VT. Additional shocks were delivered which converted the patient to sinus rhythm. The patient reported chest pain during the event. Reprogramming is anticipated to resolve the event. No intervention has been performed. The patient is stable.
Patient problems: Arrhythmia; Discomfort
MAUDE report 50789460 ↗MalfunctionSep 16, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator exhibited loss of Bluetooth telemetry. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786266 ↗MalfunctionSep 15, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781152 ↗MalfunctionSep 15, 2026Inappropriate or Unexpected Reset; Compatibility Problem
It was reported that the patient presented in clinic for Magnetic Resonance Imaging (MRI) procedure. The patient's Implantable Cardioverter Defibrillator (ICD) was put into MRI mode prior to procedure; however, the ICD inappropriately went into backup mode after the MRI was completed. Programming changes were made to restore the original ICD settings. The patient was stable throughout.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778588 ↗MalfunctionSep 15, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator exhibited loss of Bluetooth telemetry. The patient was brought into clinic and the issue was resolved. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777061 ↗MalfunctionSep 14, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762962 ↗MalfunctionSep 14, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator exhibited loss of Bluetooth telemetry. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755959 ↗MalfunctionSep 11, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743897 ↗MalfunctionSep 11, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740505 ↗MalfunctionSep 10, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724657 ↗MalfunctionSep 10, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator exhibited loss of Bluetooth telemetry. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719612 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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