FDA recall Z-2047-2025

Given Imaging Ltd. · Class I · 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)

Reason for recall

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.

Distribution

US Nationwide. Global Distribution.

Key facts

Status
Ongoing
Initiation date
2025-06-03
Report date
2025-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yokne'Am Ilit, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2047-2025