St. Jude Medical recalls Gallant VR Implantable Cardioverter Defibrillators with Bluetooth malfunction that reduces remote monitoring and battery life. Affected units have specific serial numbers and expiration dates.
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.
St. Jude Medical is recalling Gallant VR Implantable Cardioverter Defibrillators with a Bluetooth malfunction that causes loss of remote monitoring and reduced battery life. This could lead to missed health alerts and shorter device lifespan.
The Bluetooth malfunction causes the device to enter an inductive-only telemetry mode, losing remote communication. This means doctors can't monitor the device's health status remotely, and the battery may last shorter than expected.
People with Gallant VR Implantable Cardioverter Defibrillators (ICDs) who received the recalled model REF # CDVRA500Q. Those with the specific serial numbers and expiration dates listed are most at risk.
Check for the serial number (SN) and expiration date on the device label. Affected units include SN: 111009251 (exp 31-Jul-2022) and SN: 810000544 (exp 31-Oct-2022).
Look for the serial number (SN) and expiration date on the device label to confirm if it's affected.
The Bluetooth malfunction causes the device to enter an inductive-only telemetry mode, losing remote communication and reducing battery life.
Check the serial number (SN) and expiration date on the device label. Affected units include SN: 111009251 (exp 31-Jul-2022) and SN: 810000544 (exp 31-Oct-2022).
The recall record does not specify a remedy, so contact St. Jude Medical directly for guidance.
We’ve drafted a message you can send St. Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0989-2022 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-0989-2022 from St. Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
