EsoCheck CCD Cell Collection Device
Lucid Diagnostics Inc · Model 260-03614 · UDI-DI 00860002356006
Description
The Lucid Diagnostics EsoCheck CCD Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-24 | Lucid Diagnostics, Inc. | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gast |
| 2024-04-24 | Lucid Diagnostics, Inc. | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gast |
| 2023-06-02 | Covidien, LLC | Cell Collection Device 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 patie |
| 2021-08-16 | Olympus Corporation of the Americas | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Label |
| 2016-06-06 | Covidien, LLC | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patie |
| 2016-06-06 | Covidien, LLC | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patie |
| 2011-09-30 | Pentax Medical Company | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
| 2011-09-30 | Pentax Medical Company | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
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