Z-0989-2022 Class II Ongoing
FDA device recall Z-0989-2022 was initiated by St. Jude Medical, Cardiac Rhythm Management Division on March 10, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- March 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Code Information
REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990