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St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Recalled April 27, 2022 · FDA recall Z-0990-2022 · St. Jude Medical, Cardiac Rhythm Management Division
Hazard
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. · FDA Class II
Units
1
Sold at
Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Description
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.
Product
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Manufacturer(s)
St. Jude Medical, Cardiac Rhythm Management Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →