Lucid Diagnostics recalls EsophaCap sponges (EC20T20VI) due to potential detachment at narrow esophageal areas during removal, risking injury. Affected units include specific lots sold to clinical sites.
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.
Lucid Diagnostics recalls EsophaCap sponges (model EC20T20VI) because they may detach from the string during removal, especially at narrow sections of the esophagus. This could cause injury if the sponge becomes lodged or moves unexpectedly.
The sponge may detach from the string when being removed from the patient, especially at the narrowest parts of the esophagus (gastroesophageal junction or upper esophageal sphincter). This could cause the sponge to become lodged or move unexpectedly, potentially leading to injury.
Healthcare professionals using the EsophaCap sponges in clinical settings are most at risk, particularly when removing the device from patients. Patients receiving procedures with these sponges could also be affected.
Check for the model EC20T20VI on the product label. Affected units were sold in specific lots: 462 (25 units), 486 (32 units), and 501 (100 units) to clinical sites.
Look for the model number EC20T20VI on the sponge packaging or label.
The EsophaCap sponge may detach from the string during removal, especially at narrow sections of the esophagus, which could cause injury.
Model EC20T20VI (20mm diameter, 20 pores/inch).
Lots 462 (25 units), 486 (32 units), and 501 (100 units).
We’ve drafted a message you can send Lucid Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1899-2024 — Lucid Diagnostics Lucid Diagnostics Hello, I own a Lucid Diagnostics that is covered by recall Z-1899-2024 from Lucid Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
