Gallant™ CDDRA500QRecalls & reported problems
St. Jude Medical, Inc. · DR Implantable Cardioverter Defibrillator VVED DDDR · Class 3 · Implant
Data updated Oct 13, 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 Gallant implantable cardioverter defibrillator is a device implanted to treat heart rhythm problems. Its 2,997 adverse event reports often describe the device sensing electrical noise as heartbeats, losing Bluetooth connection, and shocks that were inappropriate or inadequate. The reports include 33 deaths and 835 injuries. Two open recalls name this device, both over Bluetooth problems that can prevent remote monitoring.
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
- 3,028
- Deaths reported
- 33
- Injuries reported
- 840
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 3,028 adverse event reports that list this exact device (DI 05415067032003), received between Nov 10, 2020 and Sep 30, 2026 — classified as 33 deaths, 840 injuries, 2,153 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (864 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. How this data works · Data updated Oct 13, 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 · 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-0988-2022 · Root cause: Component design/selection · FDA record ↗
Most reported problems
Device problems
- Over-Sensing864
- Failure to Interrogate640
- Adverse Event Without Identified Device or Use Problem379
- Inappropriate/Inadequate Shock/Stimulation326
- Incorrect Interpretation of Signal229
- Inappropriate or Unexpected Reset216
- Under-Sensing145
- Pacing Problem128
Patient problems
- No Clinical Signs, Symptoms or Conditions2,403
- Unspecified Infection321
- Arrhythmia135
- Insufficient Information111
- Discomfort69
- Pocket Erosion52
- Wound Dehiscence32
- Hematoma17
Recent adverse event reports
The 25 most recent of 3,028 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949907 ↗MalfunctionSep 30, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949097 ↗InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Insufficient Information
MAUDE report 50948520 ↗MalfunctionSep 30, 2026Failure to Interrogate
It was reported that the implantable cardioverter defibrillator (ICD) exhibited Bluetooth (BLE) telemetry loss. Additional information received indicated the patient presented in clinic and the BLE was succesfully restored, however, no information was provided as to how this was achieved. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947795 ↗InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient received an inappropriate shock from the Implantable Cardioverter Defibrillator (ICD). Further evaluation revealed that the right ventricular (RV) lead exhibited loss of capture, and a Computed Tomography (CT) scan confirmed cardiac perforation. At the patient's request, the entire system, including the ICD, right ventricular (RV) lead, and right atrial (RA) lead, was explanted on (b)(6)2026. The patient remained stable throughout the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941663 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented for a follow-up in the clinic with infection at the implanted device pocket site and pocket erosion. The implantable cardioverter defibrillator was visible from the opened incision site of the implanted device pocket. The physician explanted the entire system ¿ implantable cardioverter-defibrillator, right ventricular lead, and atrial lead due to resolve the issue. The patient was in stable condition.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 50933682 ↗MalfunctionSep 29, 2026Under-Sensing
It was reported that the patient presented remotely via merlin.net. Review of transmission revealed that the Implantable Cardioverter Defibrillator (ICD) exhibited under-sensing. No intervention was performed. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928255 ↗MalfunctionSep 29, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
It was reported that the patient underwent to a Magnetic Resonance Imaging (MRI) procedure without enabling MRI mode. Later it was noted that the Implantable Cardioverter Defibrillator (ICD) was in backup mode with high voltage therapy disabled. Programming changes were made, and the ICD was restored. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927996 ↗MalfunctionSep 28, 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 50915931 ↗MalfunctionSep 26, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50906530 ↗MalfunctionSep 25, 2026Failure to Interrogate
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited loss of Bluetooth telemetry. No intervention was performed. The patient had no consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900951 ↗MalfunctionSep 25, 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 50897374 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the hospital with drainage at the device implant site due to infection. The patient's implantable cardioverter-defibrillator, the right atrial lead and the right ventricular lead were explanted due to the infection. The patient was stable throughout.
Patient problems: Unspecified Infection
MAUDE report 50893288 ↗MalfunctionSep 24, 2026Failure to Capture; Under-Sensing
It was reported that the patient experienced an arrythmia. Subsequently, decreased sensing resulting in under-sensing and loss of capture were noted on the device. No intervention was performed. The patient was stable.
Patient problems: Arrhythmia
MAUDE report 50884663 ↗MalfunctionSep 24, 2026Inappropriate or Unexpected Reset
It was reported that the Implantable Cardioverter Defibrillator (ICD) went into backup mode. No intervention was reported and patient condition was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884533 ↗InjurySep 24, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
It was reported via a review of remote transmission that the device delivered an inappropriate shock due to an incorrect interpretation of signal. No patient symptoms were reported. It is unknown whether any changes were made.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883907 ↗InjurySep 23, 2026Insufficient Device Problem Information
It was reported that the device was explanted and replaced due to an unspecified device problem. No further information was reported.
Patient problems: Insufficient Information
MAUDE report 50872954 ↗MalfunctionSep 23, 2026Failure to Interrogate
It was reported that a patient presented to the emergency room for unknown reasons. The Merlin on Demand transmitter was unable to perform reading on the patient's implantable cardioverter defibrillator (ICD). No changes or interventions were reported. The patient was discharged.
Patient problems: Insufficient Information
MAUDE report 50868808 ↗MalfunctionSep 23, 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 50868315 ↗MalfunctionSep 23, 2026Over-Sensing; Pacing Problem
During an in clinic follow up, far field R-wave oversensing and inappropriate automatic mode switch were noted on the device. No intervention has been performed. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867297 ↗MalfunctionSep 19, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831632 ↗MalfunctionSep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829944 ↗InjurySep 18, 2026Capturing Problem; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829708 ↗MalfunctionSep 18, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829490 ↗InjurySep 18, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient presented remotely. A remote transmission showed that the patient was inappropriately shocked by their Implantable Cardioverter Defibrillator (ICD). No intervention was performed. The patient had no adverse consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828534 ↗
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- Entrant™ CDDRA300QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components1 recall2 deaths158 reports
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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