FDA takes up Medtronic recall of stolen laryngoscopes sold on Facebook Marketplace

FDA medical device recalls typically involve hardware that poses a risk to patients, either because they are operating or being operated incorrectly—but, on some rare occasions, they involve products that were never meant to be used in the first place.

One of the latest to attract the agency’s attention is Medtronic’s warning to healthcare providers that urged them to be on the lookout for stolen and defective laryngoscopes. 

These blade-like tools hold back the tongue to help clinicians peer down a patient’s throat during an intubation procedure or to help examine the vocal cords. As many as 5,700 of them had been bound for the scrap heap—discarded for manufacturing defects, following their assembly at a Mexico factory—but earlier this year they began popping up for sale on social media websites, namely Facebook Marketplace.

“These affected products did not pass Medtronic’s rigorous quality tests established for the product, were not released for sale, distribution, or importation and were designated for destruction,” the company said in its Sept. 27 letter to healthcare providers. 

Now, the FDA is lending its megaphone to the recall effort, while issuing a Class I label denoting a high risk of patient harm.

“All the defects and failure modes are not known to the firm because they were stolen from the intended scrap,” the agency said in its recall posting. “As such, it is not possible to rule out the major failure modes that may lead to inadequate airway support, cardiopulmonary arrest, and death.”

The FDA said that so far it has received no device complaints and no reports of injuries. Some devices were retrieved after the theft was discovered, and the Facebook postings were taken down. 

The case involves Medtronic’s light- and camera-equipped McGrath MAC video laryngoscopes. While the full extent of their distribution is unknown, the company said the pirated goods would not be shipped within their original packaging. Medtronic also listed more than 1,650 affected serial numbers but also said some products were never marked or may have had their identifiers removed. 

The company urged healthcare providers to only purchase these products directly from Medtronic or authorized distributors.