St. Jude Medical, Cardiac Rhythm Management Division: 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.

Agency Publication Date: April 21, 2022

Affected Products

Product: Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003

Product: Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990

Product: Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89825

Status: Active

Manufacturer: St. Jude Medical, Cardiac Rhythm Management Division

Manufactured In: United States

Units Affected: 3 products (1; 2; 1)

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Sources: FDA iRES · Raw API Response

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