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Given Imaging Ltd. recalls Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic
Recalled July 16, 2025 · FDA recall Z-2047-2025 · Given Imaging
Hazard
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. · FDA Class I
Units
128,202 units
Sold at
US Nationwide. Global Distribution.
Description
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
Product
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
Manufacturer(s)
Given Imaging Ltd.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →