Date Initiated by Firm | March 10, 2022 |
Create Date | April 21, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0988-2022 |
Recall Event ID |
89825 |
PMA Number | P910023S423 |
Product Classification |
Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
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Product | Gallant DR Implantable Cardioverter Defibrillator
REF # CDDRA500Q |
Code Information |
REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003 |
Recalling Firm/ Manufacturer |
St. Jude Medical, Cardiac Rhythm Management Division 15900 Valley View Ct Sylmar CA 91342-3577
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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 | 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 |
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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.
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PMA Database | PMAs with Product Code = LWS
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