St. Jude Medical recalls Gallant DR Implantable Cardioverter Defibrillators with REF # CDDRA500Q that may lose Bluetooth communication, reducing remote monitoring and battery life. Affected units were sold between 2018 and 2022.
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 DR Implantable Cardioverter Defibrillators with specific reference numbers due to a Bluetooth malfunction that prevents remote monitoring and shortens battery life. This issue could lead to missed health alerts and reduced device longevity for patients.
The device's Bluetooth malfunction causes it to enter an inductive-only telemetry mode, which stops remote communication with the device. This means doctors can't monitor the device's health remotely, and the battery may wear out faster than expected.
Patients with Gallant DR Implantable Cardioverter Defibrillators (REF # CDDRA500Q) who were implanted between 2018 and 2022. Those with the specific serial numbers and expiration dates listed in the recall are most at risk.
Check for the reference number CDDRA500Q on the device label. The serial number starts with 111018237 and expires by October 31, 2022. The device was sold between 2018 and 2022.
Look for the reference number CDDRA500Q on the device label to confirm if it's affected.
The recall is due to a Bluetooth malfunction that causes the device to enter an inductive-only telemetry mode, preventing remote monitoring and reducing battery life.
Check for the reference number CDDRA500Q on the device label. The serial number starts with 111018237 and expires by October 31, 2022.
The recall record does not specify a remedy, so affected users should 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-0988-2022 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-0988-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
