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Recall Observatory FDA recall evidence

Device product

Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

Z-0990-2022

March 10, 2022

Class II

Product summary

Firm
St. Jude Medical, Cardiac Rhythm Management Division
Event
Event 89825
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0990-2022

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

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.