Lucid Diagnostics recalls EsophaCap sponges (EC25T10VI) due to potential detachment at narrow esophageal areas during removal, risking injury. Affected units include specific lots from 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 EC25T10VI) 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's design may cause it to detach from the string when removed from the patient, particularly at the narrowest parts of the esophagus. This could lead to the sponge becoming lodged or moving unexpectedly, potentially causing injury.
Healthcare professionals using the EsophaCap sponges in clinical settings are most at risk. Patients undergoing procedures with these sponges could be affected if the sponge detaches.
Check for the model EC25T10VI on the sponge packaging. Affected units were sent to clinical sites with specific lot numbers: 483 (120 units), 502 (100 units), and 539 (99 units).
If the sponge detaches during removal, stop using it immediately and consult a healthcare provider.
The recall indicates a potential risk of detachment during removal, so it is not recommended for use until the remedy is applied.
The affected model is EC25T10VI with specific lot numbers: 483 (120 units), 502 (100 units), and 539 (99 units).
Look for the model EC25T10VI on the sponge packaging. Affected units were sent to clinical sites with the lot numbers mentioned above.
We’ve drafted a message you can send Lucid Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1900-2024 — Lucid Diagnostics Lucid Diagnostics Hello, I own a Lucid Diagnostics that is covered by recall Z-1900-2024 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.
