FDA Device recall Z-0989-2022
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q 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-0989-2022 |
| 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 VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
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# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990 |
|---|
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-0989-2022%22
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