Gallant™ CDHFA500QRecalls & reported problems
St. Jude Medical, Inc. · HF Cardiac Resynchronisation Therapy Defibrillator VVED DDDRV · Class 3 · Implant
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This St. Jude Gallant CRT-D defibrillator appears in 8,303 adverse event reports, including 58 deaths and 957 injuries. The reports mostly describe over-sensing, where the device reads false heart signals, failures to be checked by the clinic, and inappropriate shocks. Both of its 2 recalls are open: one about Bluetooth failures in some devices made before April 2022, and one about Bluetooth problems that block remote monitoring and can 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
- 8,401
- Deaths reported
- 58
- Injuries reported
- 957
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 8,401 adverse event reports that list this exact device (DI 05415067032010), received between Aug 21, 2020 and Sep 30, 2026 — classified as 58 deaths, 957 injuries, 7,384 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (5,803 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-2615-2023 · 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-0990-2022 · Root cause: Component design/selection · FDA record ↗
Most reported problems
Device problems
- Over-Sensing5,803
- Failure to Interrogate784
- Adverse Event Without Identified Device or Use Problem530
- Pacing Problem270
- Inappropriate/Inadequate Shock/Stimulation258
- Under-Sensing228
- Pacing Asynchronously192
- Inappropriate or Unexpected Reset148
Patient problems
- No Clinical Signs, Symptoms or Conditions7,457
- Unspecified Infection436
- Insufficient Information290
- Arrhythmia148
- Discomfort97
- Pocket Erosion92
- Wound Dehiscence50
- No Consequences Or Impact To Patient33
Recent adverse event reports
The 25 most recent of 8,401 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 50954796 ↗MalfunctionSep 30, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952947 ↗MalfunctionSep 30, 2026Inappropriate or Unexpected Reset
It was reported that the Implantable Cardioverter Defibrillator (ICD) was found to be in back-up operation mode before implanting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950891 ↗MalfunctionSep 30, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949880 ↗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 50949641 ↗MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949372 ↗MalfunctionSep 30, 2026Over-Sensing; Pacing Asynchronously
During remote follow up, post paced T wave oversensing and fusion were observed on the device. Technical Support was contacted and recommended reprogramming. No intervention has been performed. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946520 ↗InjurySep 30, 2026Premature Discharge of Battery
It was reported that the implantable cardioverter defibrillator exhibited premature battery depletion. The device was explanted and replaced. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941921 ↗MalfunctionSep 29, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50939899 ↗MalfunctionSep 29, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937634 ↗MalfunctionSep 29, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937616 ↗MalfunctionSep 29, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937349 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited a Synchrony Atrioventricular (Sync AV) Delta marker that displayed at the end instead of the beginning of the sequence. No changes or interventions were reported. The patient condition was not known.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934240 ↗MalfunctionSep 29, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933708 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the clinic due to pocket erosion. The physician explanted the entire ICD system due to erosion. The patient was in stable condition throughout the procedure.
Patient problems: Pocket Erosion
MAUDE report 50932638 ↗MalfunctionSep 29, 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 50927843 ↗MalfunctionSep 29, 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 50927812 ↗MalfunctionSep 29, 2026Over-Sensing
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing (PPTWOS). No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927653 ↗InjurySep 29, 2026High impedance; Loose or Intermittent Connection
It was reported that the patient underwent a device exchange procedure on (b)(6) 2026. After the procedure, the patient was monitored remotely via Merlin.net. Review of the transmission revealed that the right ventricular (RV) lead exhibited high, out-of-range defibrillation impedance, and the left ventricular (LV) lead exhibited high, out-of-range pacing impedance. Diagnostic imaging confirmed that the leads were not properly secured in the set screws of the Implantable Cardioverter Defibrillator (ICD). During the lead revision procedure, the RV lead was found to be disconnected from the ICD, and the LV lead was also found to be loose. The RV and LV leads were cleaned and secured by tightening the set screws, and the impedance values returned to the normal range. The patient remained stable throughout the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927573 ↗MalfunctionSep 28, 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 50916906 ↗MalfunctionSep 28, 2026Over-Sensing; Pacing Problem
It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed far-field R-wave oversensing resulted in inappropriate Automatic Mode Switch (AMS). 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 50916409 ↗MalfunctionSep 28, 2026Over-Sensing
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited post-paced t-wave oversensing. No intervention was performed and the patient's status was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910854 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the hospital with infection and was tested positive for bacteremia. The physician stated that the infection was not caused by Abbotts' devices. The patient's implantable cardioverter-defibrillator, the right atrial lead, the right ventricular lead and the left ventricular lead were explanted due to the infection. The patient was stable throughout.
Patient problems: Unspecified Infection
MAUDE report 50910621 ↗MalfunctionSep 26, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50906570 ↗MalfunctionSep 25, 2026Over-Sensing
During a remote 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903455 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- 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
- Claria MRI™ Quad CRT-D SureScan™ DTMA1QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)22 deaths1,479 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.