Official recall record
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDD
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-08-16
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05415067031990
- Brand on record
- Abbott Medical
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-10-06 · US FDA — Medical Devices
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 - 2025-10-06 · US FDA — Medical Devices
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 - 2024-11-21 · US FDA — Medical Devices
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All 5 official recall notices naming Abbott Medical on this site →