Health Canada — Medical Devices · Canada · 2024-07-23 · Type I
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Reported risk: Medtronic is issuing a voluntary recall for item codes 300-000-000 and 300-200-000 (section 1). This notice also includes information related to an addendum to the instructions for use (IFU) for item code 301-000-000 (section 2). Section 1 (for item codes 300-000-000 and 300-200-000 ) : Customers should immediately discontinue use of these devices that are being recalled. Customers should uninstall the battery assembly from these devices, dispose as per local procedure and follow manufacturer's instructions for returning the devices that are being recalled. To date, manufacturer has determined that the battery management system within the devices being recalled is not sufficient to mitigate against depletion of the battery voltage below the design threshold. Batteries that are depleted below the design threshold may increase the risk of the battery becoming unstable, which may lead to a thermal event followed by a risk of explosion. A thermal event followed by a risk of explosion of the battery assembly can potentially cause caregivers and/or patients to experience burns, lacerations, tinnitus, hearing impairment and acoustic shock. The potential for a delay to treatment, respiratory failure, hypoxia, unspecified tissue injury, scar tissue, foreign body in patient or caregiver, tooth loss, and eye injury also exist. There also exists the potential for damage to surrounding equipment or surfaces. This notice follows the receipt of two customer reports stating that the installed battery experienced a thermal event, which resulted in an explosion of the battery assembly before patient use. In one of these two instances, there were caregiver injuries. Section 2 (for item code 301-000-000) : Item code 301-000-000 are not being removed and are safe and effective for patient use. Next-generation laryngoscopes include an advanced battery management system that maintains the battery within intended voltage usage levels and renders them inoperable when the battery voltage falls below the device design threshold. Manufacturer is issuing an addendum to the instructions for use (IFU). this addendum will include the following warnings regarding proper battery handling. improper battery handling can increase the risk of a thermal event. Battery assembly (340-000-000) is labelled with a "use by date". Do not use a battery past the "use by date". Refer to the product instructions for use (IFU) for proper battery storage conditions. Any battery assemblies that have not been stored in these conditions should be disposed of per local guidelines. Do not use a battery assembly, installed or uninstalled, that has been dropped as it may have sustained internal damage that is not visible. Dispose of any dropped battery assembly in accordance with facility's procedure and replace with a new labeled battery assembly. Recall start date: July 18, 2024
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