medical Class II Updated 2022-04-27

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

Recalled Product

Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010
View official government recall

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