Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Check against the official notice below — it lists the full affected range.
St. Jude Medical is recalling one Gallant HF Implantable Cardioverter Defibrillator device due to a Bluetooth malfunction that occurs after implantation. The defect causes the device to lose Bluetooth communication and enter an inductive-only telemetry mode, which prevents remote monitoring of the device and reduces battery longevity.
The affected device was distributed worldwide, including in Florida, Kentucky, France, and Czech Republic. The recalled device has serial number 111004346 with an expiration date of June 30, 2022. The source does not specify what remedy an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic. Quantity: 1 Lot/code info: REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.