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.
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 medical device recall involving a Bluetooth communication malfunction on life-critical implanted cardiac devices. Although no illnesses or injuries have been reported, the potential for excessive power draw affecting battery longevity represents a risk of harm where injury has not yet been documented.
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. The recall is due to a Bluetooth malfunction caused by a crystal component defect in the Bluetooth Low Energy (BLE) circuit.
When the malfunction occurs, the affected device enters an inductive telemetry-only mode and loses Bluetooth communication capability. In some instances, the affected circuit may draw excessive power, potentially affecting the device's battery longevity.
The affected devices were distributed nationwide in the United States and internationally across multiple countries. Patients implanted with affected devices should contact their physician or Abbott Medical regarding assessment and guidance on potential device replacement or ongoing monitoring.
The recalled product
- 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:
- Manufacturer
- Abbott Medical
- Hazard
- bluetooth-malfunction
- battery-drain
- component-defect
Distribution
Distribution scope not specified by the agency.
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