Device recall
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.
- Recall number
- Z-3090-2026
- Event id
- 99626
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Given Imaging Ltd.
- Report date
- Sep 16, 2026
- Posted
- Sep 11, 2026
- Initiated
- Aug 6, 2026
- Center classification date
- Sep 10, 2026
- Product code
- FFT
- Device type
- Electrode, Ph, Stomach
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 127,416
- Code info
- Product Number FGS-0635 UDI-DI (GTIN) 07290101369707 Product Number FGS-0636 UDI-DI (GTIN) 07290101369714 Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Yokne'Am Ilit, Israel