Class 2 Device Recall Gallant

• Date Initiated by Firm: March 10, 2022
• Create Date: April 21, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0990-2022
• Recall Event ID: 89825
• PMA Number: P910023S423
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
• Code Information: REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010
• Recalling Firm/ Manufacturer: St. Jude Medical, Cardiac Rhythm Management Division; 15900 Valley View Ct; Sylmar CA 91342-3577
• For Additional Information Contact: Ms. Alicia Swanson,; 408-845-3427
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: Abbott issued a Safety Notification For a subset of Gallant ICDS and CRT-D, Models CDVRA500Q, CDDRA500Q and CDHFA500Q on March 10, 2022. Notification was hand delivered in US. The notification includes the Patient Management Recommendations: -As the devices are unable to be followed using remote monitoring via Bluetooth connectivity, follow-ups should be conducted in-clinic using inductive telemetry. - Abbott has developed a process to attempt recovery of Bluetooth communication via a device firmware upgrade. If remote monitoring via Bluetooth communication is desired, please work with your local Abbott representative to schedule a firmware upgrade. Please complete and return the included Acknowledgement Form to CRMNotification@abbott.com and maintain a record of this notice to ensure effectiveness of the communication. For any question, please contact Abbott Technical Support at 1-800-722-3774 (U.S.).
• Quantity in Commerce: 1
• Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LWS