The Recall Desk
HighFDA (Devices)·Z-0990-2022·Announced 2022-04-27

Gallant HF Implantable Cardioverter Defibrillator Bluetooth Malfunction Impairs Remote Monitoring

The Gallant HF Implantable Cardioverter Defibrillator (REF# CDHFA500Q) may experience a Bluetooth malfunction that prevents remote monitoring and reduces battery life. Consult your healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a cardiac implantable device. The source text does not report any hospitalizations, injuries, or deaths. The hazard represents potential risks to patient safety—loss of remote monitoring and reduced battery life—but no actual harm has been reported, placing it in the High category per the rubric.

Plain-English summary

The Gallant HF Implantable Cardioverter Defibrillator (ICD), model reference CDHFA500Q, manufactured by St. Jude Medical, Cardiac Rhythm Management Division, is subject to this recall.

The device may experience a Bluetooth malfunction that causes it to enter an inductive-only telemetry mode. This results in loss of Bluetooth communication, preventing remote monitoring of the device and causing reduced battery longevity.

The affected device was distributed worldwide, including in the United States (Florida and Kentucky), France, and Czech Republic.

Patients with this device should contact their healthcare provider or St. Jude Medical for guidance regarding this issue.

The recalled product

Product
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
Category
Medical Device — Cardiac Implant
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • REF# CDHFA500Q SN #111004346
  • Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by St. Jude Medical, Cardiac Rhythm Management Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · St. Jude Medical, Cardiac Rhythm Management Division

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Same hazard · bluetooth malfunction

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