Recall Z-3090-2026 ยท FFT Electrode, Ph, Stomach
Given Imaging Ltd.
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.
| Date | Sep 11, 2026 (initiated Aug 6, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On August 10, 2026, the firm notified consignees via "URGENT: MEDICAL DEVICE RECALL" letters. Please note this is a separate recall from that initiated in June 2025, which involved the same issue, but a different underlying cause. Customers were instructed to do the following: 1. Immediately identify and quarantine all unused and affected devices. 2. Return all product to Medtronic for replacement as described in the letter. 3. Complete and return the included customer response form to the firm via email: rs.gmbmitgfca@medtronic.com, even if you do not have unused affected inventory. 4. Not |
| Quantity | 127,416 |
| 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, Netherlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.