FDA Device recall Z-0990-2022
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q by St Jude Medical Cardiac Rhythm Management Division, citing 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 B….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0990-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-10 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | US |
Product
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Reason
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.
Identifiers
| code_info | REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0990-2022%22
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