FDA issues highest-level recall for missing Medtronic video scopes

The U.S. Food and Drug Administration issued a Class I recall, its most serious, for Medtronic video scope medical devices that were stolen and are being sold on social media platforms.

The company is recalling McGrath Mac video laryngoscopes, saying the 5,709 stolen laryngoscopes in question did not pass Medtronic quality tests and were slated for destruction.

The risk is the possible medical complications from defective devices. According to the FDA recall notice, that could include "inadequate airway support, cardiopulmonary arrest, and death."

Medtronic, based in Ireland but run from Fridley, declined comment. The company issued a public safety notification at the end of September alerting clinicians and patients about the stolen medical scopes.

A laryngoscopy is an examination of the larynx. The video laryngoscope is used by clinicians to get a view of a patient's vocal cords during the procedure. The scope has an LED light and a miniature camera.

"After the theft was discovered, some devices were retrieved, and a For Sale posting on Facebook Marketplace was taken down," the FDA recall notice said. "However, it is unknown where the devices were distributed."

The FDA assigns Class I recalls for devices that "may cause serious injuries or death."

The recall covers devices that were distributed between July 2019 and July 2022. There have been no complaints about the device, and Medtronic said that no injuries or deaths have been reported.

The defective devices are not appropriately packaged and labeled. Some are missing serial numbers.

Medical device recalls are typically initiated by companies. The FDA often takes a few months to classify the severity of the recall.