Lucid Diagnostics Inc. announced that the legacy EsophaCap sponge-on-a-string (SOS) esophageal cell collection device, which it briefly supplied to third-party institutions for their own research studies, has been subjected to a Class II FDA recall due to two serious device failures reported in a recent publication of one of these studies. EsophaCap is not a commercial Lucid product. The technology underlying the EsophaCap SOS was first FDA-cleared in 1993 and then again in 2020 (K203450).

Lucid acquired the technology for research purposes in 2021 and supplied it to two academic institutions for their ongoing research studies until early 2022. In a recently-published research article of one of these studies, two patients suffered from serious device failures, specifically SOS detachments, one of whom required invasive endoscopic retrieval. These detachments were similar to previously-reported detachments of the Cytosponge Cell Collection Device, an SOS manufactured by Medtronic, which led to two Class II FDA recalls, including a June 2023open global recall, which remains in effect.

In this most-recent recall, Medtronic reported to FDA that patients "may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration." In an accompanying Urgent Field Safety Notice sent to customers in the United Kingdom, Medtronic reported "nine (9) customer complaints where the sponge detached from the string during the removal of the device from the patient. All nine (9) patients underwent an unplanned urgent secondary intervention (upper endoscopy) where the detached sponge was retrieved from the stomach or esophagus" between December 2022 and May 2023. As the manufacturer of record, Lucid proactively informed the FDA of the reported device failures and concluded that a Class II recall of the EsophaCap SOS was necessary and was made effective as of April 25, 2024.

Notice Letters were sent to the two research institutions which had been supplied with devices.