Gallant recallZ-0988-2022 · St. Jude Medical, Cardiac Rhythm Management Division · initiated Mar 10, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St. Jude Medical, Cardiac Rhythm Management Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Component design/selection
What the company is doing
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 [email protected] 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.).
Recall details
- Recall number
- Z-0988-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 10, 2022
- Recalling firm
- St. Jude Medical, Cardiac Rhythm Management Division
- Quantity
- 1
- Product code
- LWS
- FDA submissions
- P910023S423
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Product description
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Code information (models, lots, serial numbers)
REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gallant™ CDDRA500QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components2 recalls33 deaths3,028 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89825).
- Z-0989-2022 · Open, ClassifiedGallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
- Z-0990-2022 · Open, ClassifiedGallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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