Recall Z-3090-2026— Given Imaging Ltd.
Class I · Ongoing
Class I FDA medical device recall by Given Imaging Ltd., initiated 2026-08-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Given Imaging Ltd.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-08-06
- Firm location
- Yokne'Am Ilit, Israel
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.