FDA-Device2026-09-16Class IPROCESSING DEFECT

Given Imaging Bravo CF capsule delivery device recalled for attachment failure risk

OTHERNationwide distributionMedical devices

What this means

The Bravo CF capsule delivery device is used during esophageal pH monitoring procedures to attach a small capsule to the esophagus. The capsule may fail to attach properly or detach from the delivery device during use. This can result in the capsule being inhaled, perforating the esophagus, blocking the airway, or causing bleeding.

If you are a healthcare facility using this device, contact Given Imaging Ltd. for instructions on affected lot numbers (64553F through 68912F with expiration dates on or before October 20, 2027).
Do not use affected units for new procedures.
If a patient has undergone a procedure with this device and experiences chest pain, difficulty swallowing, vomiting blood, or breathing problems, seek immediate medical attention.

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The agency's original wording

Hazard

Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide distribution. US nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Czech Republic, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Luxembourg, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, and United Kingdom.

Affected count

127,416

Manufactured in

New Industrial Park, 2, Hacarmel St.; Ta Do'Ar 258, Yokne'Am Ilit, Israel

Products

Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3090-2026

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