Recall Z-2047-2025 ยท FFT Electrode, Ph, Stomach
Given Imaging Ltd.
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
| Date | Jul 10, 2025 (initiated Jun 3, 2025) |
| Status | Open, Classified |
| Reason | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. |
| Root cause | Process control |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers beginning on 6/3/25. Actions: "Immediately identify and quarantine all unused FGS-0635 (Bravo CF capsule delivery device, 5-pk)and FGS-0636 (Bravo CF capsule delivery device, 1-pk). See Attachment A and Attachment B for affected lot numbers. "Return all unused, affected product(s) to Medtronic for replacement/credit as described on the Customer Confirmation Form. "Please complete and e-mail the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com, even if you do not have unused inventory. "Pass on this no |
| Quantity | 128,202 units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES Given Imaging , Ltd., Dec 1, 2010 |