St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

Recall date

March 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0990-2022

FDA classification

Class II

Brand / firm

St. Jude Medical, Cardiac Rhythm Management Division

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q