Capsule delivery device Recall: Given Imaging Bravo CF
The FDA recall covers the Bravo CF capsule delivery device (5-pack FGS-0635 and 1-pack FGS-0636) from Given Imaging Ltd. The capsule may fail to attach to the esophagus or detach from the delivery device, risking aspiration/inhalation, esophageal perforation, airway obstruction, hemorrhage, esophageal laceration, delayed diagnosis, or retained foreign bodies. It has worldwide distribution including the United States; expiration dates prior to and including October 20, 2027 apply to lot numbers 64553F through 68912F.
| Brand | Given Imaging Ltd. |
|---|---|
| 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. |
| Severity | critical |
| Units affected | 127416 |
| 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. |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you or a patient were treated with an affected Bravo CF device, contact the treating facility to determine exposure to FGS-0635 or FGS-0636 products.
- Do not use any affected devices; defer any planned procedures involving these devices until advised otherwise by a clinician.
- If you experience symptoms such as coughing, chest pain, trouble swallowing, or breathing difficulties, seek immediate medical attention.
How to identify the recalled item
| Lot / date codes | 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) |
|---|---|
| Lot / date codes | 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) |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.