FDA announces Class 1 recalls for upper airway stimulation system, MRI components

Editor's Note

A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8.

Class 1 is the most severe category, indicating risk of serious injury or death. In the case of the UAS system, FDA reports that Inspire Medical Systems Inc. is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028—a component of the Inspire UAS that stores therapy settings and stimulates the hypoglossal nerve to maintain airway potency during sleep—due to “risk of system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy.”

Although no injuries or deaths have been reported, the issue presents a risk of “stimulation below normal therapeutic levels and/or early depletion of the battery (resulting in - loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death.” FDA urges providers to notify patients and schedule appointments to ensure Inspire therapy is working properly.

The recalled MRI component is Phillips North America LLC’s SENSE CL Torso (1.5T and 3.0T) 16-element, receive-only coil, which are designed for imaging the torso and abdomen with the 1.5T or 3.0T MR scanners. According to the FDA report, these coils present the risk of overheating and causing serious burns and death. There have been 12 injuries and no deaths reported. 

Customers are advised continue using the identified coils in accordance with updated instructions for use (IFU), which now  include guidance on positioning the coil close to the bore and not exceeding 45 minutes of examination time. Users also should avoid first level operating mode/high SAR scans and always use dedicated pads and mattresses provided with the coils.