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U.S. Department of Health and Human Services

Class 2 Device Recall Gallant

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  Class 2 Device Recall Gallant see related information
Date Initiated by Firm March 10, 2022
Create Date April 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0989-2022
Recall Event ID 89825
PMA Number P910023S423 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product Gallant VR Implantable Cardioverter Defibrillator
REF # CDVRA500Q
Code Information REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801;  SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990
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 2		 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 2
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 and Original Applicant = Abbott Medical
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