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U.S. Department of Health and Human Services

Class 2 Device Recall EsophaCap

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 Class 2 Device Recall EsophaCapsee related information
Date Initiated by FirmApril 24, 2024
Date PostedMay 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1900-2024
Recall Event ID 94510
510(K)NumberK203450 
Product Classification Esophagoscope (flexible or rigid) - Product Code EOX
ProductBrand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
Code Information Lot Code: Product sent out to clinical site: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 483 (Qty: 120), 502 (Qty: 100) Product at Distributor in Quarantine: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 539 (Qty: 99)
Recalling Firm/
Manufacturer		 Lucid Diagnostics, Inc.
200 Foxborough Blvd Ste 300
Foxboro MA 02035-2872
For Additional Information ContactMatthieu Ennis
1-216-5366527
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce220 units (US)
DistributionUS Nationwide distribution in the states of MN, MD.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EOX
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