Legacy Sponge-on-a-String Esophageal Cell Collection Device Subject of Class II FDA Recall
NEW YORK, May 9, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), 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.
- In addition, troubling reports of serious device failures have plagued SOS devices for many years, leading to multiple Class II FDA recalls similar to this one.
- Dr. Aklog added, "In stark contrast, Lucid's EsoCheck® Esophageal Cell Collection Device , with its patent-protected Collect+Protect™ technology, is a modern groundbreaking technology.
- 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 2023 open global recall , which remains in effect.
- 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.