Bravo recallZ-3090-2026 · Given Imaging Ltd. · initiated Aug 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Given Imaging Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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: [email protected], even if you do not have unused affected inventory. 4. Notify all those who need to be aware within your organization, or those to whom affected product was transferred/distributed. 5. Maintain a copy of the recall letter for your records. If you have any questions regarding this communication, please contact your local Medtronic Representative or call 720-774-3454.
Recall details
- Recall number
- Z-3090-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2026
- Posted by the FDA
- Sep 11, 2026
- Recalling firm
- Given Imaging Ltd.
- Quantity
- 127,416
- Product code
- FFT
- 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.
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.
Code information (models, lots, serial numbers)
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)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Bravo FGS-0635Given Imaging, Inc. · Electrode, pH, stomach2 recalls1,621 reports
- Bravo FGS-0636Given Imaging, Inc. · Electrode, Ph, Stomach2 recalls820 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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