Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used…
Given Imaging Ltd. · Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruct…
Open FDA's page for this record- Cfres ID
- 222013
- Product res number
- Z-3090-2026
- Event date initiated
- 2026-08-06
- Event date posted
- 2026-09-11
- Recall status
- Open, Classified
- Res event number
- 99626
- Product code
- FFT
- Firm FEI number
- 3003348376
- Recalling firm
- Given Imaging Ltd.
- Address 1
- New Industrial Park 2 Hacarmel St. Ta Do'Ar
- City
- Yokne'Am Ilit
- Postal code
- 258
- Country
- Israel
- Additional info contact
- Sabrina Zimring 720-7743454
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 127,416
- 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 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)
- 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.
- 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. 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.
- Distribution pattern
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.
- Harmonized identifiers (openFDA)
- Device name
- Electrode, Ph, Stomach
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1400
- Device class
- 1
- K number
- K902366, K955018, K853280, K913387, K945069, K822815, K896288, K914624, K850074, K961346, K853648, K931963, K863298, K911825, K870606, K883960, K871922, K102543, K910694, K903646, K891410, K811083, K002028, K850361, K852289, K862929, K872929, K920849, K841384, K854514, K862536, K925405, K834512, K912772, K871921, K875369, K874710, K934434, K850778, K820566 +9 more
- Registration number
- 3039167637, 9710107, 3009106214, 2023374, 3011219572, 3016854619, 3018094310, 3007662958
- FEI number
- 3039167637, 3003348376, 3009106214, 2023374, 3011219572, 3016854619, 3018094310, 3007662958