Category: FDA Updates

FDA Updates

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

FDA Updates

Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits

AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.

FDA Updates

Baxter Issues Correction for Novum IQ Infusion Pump Over Underinfusion Risk

The correction follows reports that extended standby time or leaving the pump powered off with an administration set loaded may reduce flow delivery.

Clearances

FDA Clears Nanox.ARC X Imaging System

The system is cleared to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal, and paranasal indications.

Recalls

Smiths Medical Recalls Endotracheal Tubes Over Ventilation Risk

Devices are being removed from use after certain sizes were found to have smaller diameters than expected, potentially limiting airflow. Eight injuries have been reported.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.