FDAApril 24, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

lucid diagnosticslucid

UPCs

00860007510977

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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