GallantRecalls & reported problems across all models

We found 8 models of Gallant by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 12,885 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2020 and Sep 30, 2026 — classified as 115 deaths, 2,265 injuries, 10,501 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (6,969 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Gallant recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. 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 ↗

5. 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 · Recall details · FDA record ↗

Most reported Gallant problems

Gallant models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Gallant™ CDHFA500Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls58 deaths8,401 reports
• Gallant™ CDDRA500Q

  Pacemaker/icd/crt non-implanted components
  2 recalls33 deaths3,028 reports
• Gallant™ CDVRA500Q

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls22 deaths1,164 reports
• Gallant™ CDHFA500D

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death131 reports
• Gallant™ CDHFA500T

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death71 reports
• Gallant™ CDDRA500T

  Implantable cardioverter defibrillator (non-CRT)
  49 reports
• Gallant™ CDHFA500B

  Pulse-generator, single chamber, sensor driven, implantable
  29 reports
• Gallant™ CDVRA500T

  Implantable cardioverter defibrillator (non-CRT)
  12 reports

Recent Gallant adverse event reports

The 15 most recent reports across all models, 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, 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, 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 ↗
• 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 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, 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 ↗
• 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 ↗
• 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 ↗

Other St. Jude Medical, Inc. products

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