Lucid SOS esophageal cell collection device subject to Class II FDA recall

Lucid Diagnostics (LUCD), a majority-owned subsidiary of PAVmed (PAVM), announced that the 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. 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.