Recall Z-1899-2024 ยท EOX Esophagoscope (Flexible Or Rigid)
Lucid Diagnostics, Inc.
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: No
| Date | May 24, 2024 (initiated Apr 24, 2024) |
| Status | Open, Classified |
| Reason | 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 gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal. |
| Root cause | Under Investigation by firm |
| Action | On April 24, 2024 direct customers were sent notification letters via email with recall instructions. Effectiveness Checks: The signed Acknowledgment and Receipt forms must be returned along with any product that is still in-hand at the clinical sites. Customer Follow-up: Follow-ups will be conducted via phone and email for customers who do not respond. Returned Product: Returned product will be put into quarantine until all recalled product is under our control. Access is limited to authorized personnel only. It will then be destroyed. Destruction: Devices will be cut and disposed of. Once t |
| Quantity | 157 units (US) |
| Distribution | US Nationwide distribution in the states of MN, MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) Capnostics, LLC, May 4, 2021 |