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Recall Observatory FDA recall evidence

Device product

Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

Z-0989-2022

March 10, 2022

Class II

Product summary

Firm
St. Jude Medical, Cardiac Rhythm Management Division
Event
Event 89825
Status
Ongoing
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0989-2022

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.