Product Safety Recalls

Product Recall Tracker

St. Jude Medical, Cardiac Rhythm Management Division Recall 89825

Description: Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

St. Jude Medical, Cardiac Rhythm Management Division Recall 89825 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0990-2022
Event ID89825
Event DescriptionGallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Quantity1
Recall ReasonBluetooth 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.
Device Classification20220427
Device Code InfoREF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010
Center Classification Date20220421
Recall Initiation Date20220310
Recalling FirmSt. Jude Medical, Cardiac Rhythm Management Division
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.