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
This recall is currently active, issued May 24, 2024. It was issued by Lucid Diagnostics, Inc..
- Company
- Lucid Diagnostics, Inc.
- Recall Initiated
- April 24, 2024
- Posted
- May 24, 2024
- Recall Number
- Z-1899-2024
- Quantity
- 157 units (US)
- Firm Location
- Foxboro, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of MN, MD.
Lot / Code Info
Lot Code: Product Sent to Clinical Site: Part #: EC20T20VI ; GTIN Number: 00860007510953 ; Lot #'s: 462 (Qty: 25), 486 (Qty: 32), 501 (Qty:100) Product at Distributor in Quarantine: Part #: EC20T20VI ; GTIN Number: 00860007510953 ; Lot #'s: 486 (Qty: 18), 540 (Qty: 97)
Root Cause
Under Investigation by firm
Action Taken
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 the string is cut, the device will no longer be functional to use. PD1 Quarantined: 115 PD2 Quarantined: 99 Preventive Action Taken by Firm: All EsophaCap product in the field will be returned to Lucid Diagnostics. The EsophaCap product is no longer manufactured for the clinical studies. The last manufactured product was February 2023.