EsophaCap Sponge May Detach From String During Removal
Lucid Diagnostics is recalling EsophaCap medical devices (220 units in MN and MD) because the sponge may detach from the string during removal, particularly at esophageal sphincters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for sponge detachment during removal, with no reported illnesses or injuries. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Lucid Diagnostics, Inc. is recalling EsophaCap (Model EC25T10VI) medical devices distributed in the United States. The recall affects 220 units in Minnesota and Maryland: 120 units (Lot 483) and 100 units (Lot 502) sent to clinical sites, plus 99 units (Lot 539) quarantined at a distributor.
The EsophaCap sponge may detach from its string during device removal from the patient. Detachment risk is highest at the esophageal sphincters, which are the narrowest parts of the esophagus: specifically at the lower sphincter (gastroesophageal junction) or the upper sphincter (between the pharynx and esophagus).
Healthcare providers and patients should contact their healthcare facility immediately if they have received or are scheduled to receive this device. Lucid Diagnostics is working with the FDA on this Class II recall.
The recalled product
- Product
- Brand 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
- Manufacturer
- Lucid Diagnostics, Inc.
- Hazard
- Affected units
- 220
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
- Lot #'s: 539 (Qty: 99)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lucid Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Lucid Diagnostics, Inc.
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