St. Jude Medical recalls Gallant HF Implantable Cardioverter Defibrillators with specific serial numbers due to Bluetooth malfunction causing loss of remote monitoring and reduced battery life.
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 HF Implantable Cardioverter Defibrillators with certain serial numbers because a Bluetooth malfunction can cause the device to stop communicating with doctors and reduce battery life. This means patients may not get timely care if their device fails.
The device's Bluetooth malfunction causes it to enter an inductive-only telemetry mode, which stops remote communication with doctors. This can lead to reduced battery life and potential delays in medical care if the device fails.
Patients with Gallant HF Implantable Cardioverter Defibrillators (REF# CDHFA500Q) and specific serial numbers are affected. Those with the device are most at risk if the Bluetooth issue prevents remote monitoring.
Check for the serial number (SN) starting with 111004346 and expiration date of June 30, 2022, on the device label. The product is sold under the Gallant HF Implantable Cardioverter Defibrillator model.
Verify if your device has the serial number SN #111004346 and expiration date 30-Jun-2022.
The recall is due to a Bluetooth malfunction that causes the device to enter an inductive-only telemetry mode, resulting in loss of remote communication and reduced battery life.
Check your device's serial number and expiration date; if it matches the recalled model, contact St. Jude Medical for further instructions.
The recall indicates reduced battery life and loss of remote monitoring, but no specific mention of serious injury risk in normal use.
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-0990-2022 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-0990-2022 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.
