Dive Brief:
- Stolen Medtronic Covidien laryngoscopes that were offered for sale on Facebook Marketplace have received a Class 1 recall label from the Food and Drug Administration.
- The video laryngoscopes were defective and slated to be destroyed before they were discovered stolen. Some devices were retrieved after the theft was discovered, and the Facebook posting was taken down, the FDA said in its recall notice.
- A total of 5,709 devices were recalled in the U.S., but it is not known where the laryngoscopes may have been distributed, the FDA said. No injuries related to the issue were reported.
Dive Insight:
Medtronic issued a safety notice in September to let the public know that the defective McGrath MAC video laryngoscopes were stolen and offered for sale illegally by unauthorized parties on social media platforms. The company said it was working with law enforcement and regulators to recover the products.
The devices normally are used by licensed healthcare providers to facilitate intubation of the trachea. The tools have a light and miniature camera to provide a view of the larynx during medical procedures.
Use of one of the defective devices, which did not pass Medtronic quality tests, could cause patient harm, including respiratory failure, insufficient oxygen supply or tissue damage, the company said.
“It is not possible to rule out the major failure modes that may lead to inadequate airway support, cardiopulmonary arrest, and death,” according to the FDA’s notice.
Medtronic warned that its products should be purchased only from the company directly or its authorized dealers. Products that are not in labeled packaging containers or do not have serial numbers marked on the device should not be used.
A Medtronic spokesperson did not provide an update on the theft investigation when contacted by MedTech Dive.