The Recall Desk

FDA (Devices) recall action 92923

Abbott Medical recalled 2 products on 2023-09-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-09-27
Critical
0
Units
67,121

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2023-09-27

    Abbott Implantable Defibrillator Devices Recalled for Bluetooth Malfunction

    Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.

    Product
    Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary f
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    Abbott Cardiac Defibrillators Recalled for Bluetooth Circuit Component Failure

    Abbott recalled certain ICD and CRT-D devices manufactured before April 2022 due to a Bluetooth malfunction from a crystal component defect in the BLE circuit. The malfunction causes loss of Bluetooth communication, and in some cases, excessive power drain affecting battery longevity.

    Product
    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator:
    Category
    Distribution
    0 states
Abbott Medical recalled 2 products on 2023-09-27 · The Recall Desk