The FDA is amplifying a recall from Medtronic over camera-equipped laryngoscopes containing battery packs that may overheat or explode under certain circumstances.
The medtech giant previously notified its customers of the issue in July, related to its McGrath MAC and MAC EMS video laryngoscopes.
In August, the FDA categorized the efforts as a Class I recall, its most serious, and this week it issued a new missive to make sure healthcare providers dispose of the potentially faulty batteries. The agency said it is aware of one reported injury, but no deaths.
The recall spans two generations of the device, including more than 30,000 units distributed worldwide. The earlier model should no longer be used and returned to Medtronic, according to the FDA, while its battery assembly should be thrown away properly.
The next-generation version, meanwhile, may be kept in service as long as the battery assembly was stored correctly, never dropped or damaged, and is still within its expiration date.
The FDA said that some batteries “may deplete below its designed threshold. If this happens, it increases the risk of battery instability and may lead to increased battery temperature and a potential explosion.”
Some of Medtronic’s McGrath laryngoscopes were also subject to a Class I recall last year but for a completely different reason. According to the company, the intubation hardware began turning up for sale on social media websites, such as Facebook Marketplace, after some 5,700 units were determined to be faulty and slated by the factory for destruction.
The FDA later reported that some of the pirated devices were retrieved after the theft and the Facebook postings were taken down.