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.
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 of implantable cardiac devices due to a confirmed Bluetooth malfunction and potential battery degradation. No hospitalizations or injuries have been reported. Per the rubric, this is a risk-of-harm product category without reported injury, warranting a score of 3.
Plain-English summary
Abbott Medical is recalling certain Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices manufactured prior to April 2022 due to a Bluetooth malfunction. The affected models include the Gallant HF, Neutrino HF, and Entrant HF variants, with approximately 29,088 devices affected.
The malfunction stems from a crystal component issue within the Bluetooth Low Energy (BLE) circuit. This causes the device to enter an inductive telemetry-only mode, resulting in loss of Bluetooth communication.
In some cases, while Bluetooth communication is unavailable, the affected circuit may draw excessive power, potentially affecting battery longevity. The devices were distributed nationwide in the United States and internationally.
The recalled product
- 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
- Manufacturer
- Abbott Medical
- Hazard
- bluetooth-malfunction
- excessive-power-drain
- wireless-communication-loss
- battery-degradation
Distribution
Distribution scope not specified by the agency.
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