iRhythm: FDA Publishes Warning Letter to Company Citing Several Problems with Labelling and Data Storage, Potentially Paving Path for Recall

Published on Jun 06, 2023

Earlier this morning, the FDA published a lengthy warning letter the agency had sent to heart monitoring company iRhythm (IRTC) regarding the marketing of its Zio AT System as providing “near real-time monitoring” for immediate monitoring of “high-risk patients.” However, as the FDA noted, the company’s device typically provides after-the-fact reports and often fails to alert cardiologists of critical health events that resulted in patient deaths.

A Capitol Forum review of injuries and deaths reported to the FDA finds several instances of iRhythm’s devices failing to report critical information to doctors. A common theme in some of the reports is the fact that the device stops submitting information after 500 unique events, a limitation that the FDA found is not disclosed to doctors.

In the warning letter, the FDA cited numerous instances of iRhythm having knowledge of such data access and doctors’ misunderstandings of those capabilities that the company declined to rectify. Moreover, the FDA noted that iRhythm failed to fix these issues after the agency privately notified the company of them during prior inspections.

“This is a lengthy warning letter,” Marc Sanchez, an FDA attorney and consultant, told The Capitol Forum, “there are several issues in here that would merit their own warning letters. There are problems with their 510(k) applications and labelling, problems in their responses to inspection findings, problems in their reporting of adverse events to the agency. This is really a kitchen sink warning letter.”

“From the looks of it, the FDA has taken a good deal of effort to privately bring iRhythm into compliance,” Sanchez added, “now they have gone to publicly admonishing them. This is a precursor to say that if they went to court for an injunction, they could show the judge they have exhausted every available step.”

Asked if the letter could be a precursor to a recall, Sanchez said that “the FDA appears to have taken the appropriate steps leading up to that. I would not be surprised to see a recall based on some of the things in this warning letter.”

The Zio AT represents approximately 13% of Truist’s estimated 2023 revenue for the company and is a growth engine, according to a Truist equity research report published on May 30.

iRhythm did not immediately respond to a request for comment.