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)
Recall
- Recall Number
- Z-2047-2025
- Event Number
- 97029
- Firm
- Given Imaging Ltd. New Industrial Park
- FEI Number
- 3003348376
- Product Code
- FFT
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 3, 2025
- Posted
- July 10, 2025
- Address
- 2 Hacarmel St. POB 258, Yokne'Am Ilit Israel
Description
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)
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.
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 [email protected], even if you do not have unused inventory. "Pass on this notice to all those who need to be aware within your organization or to any organization where the affected product has been transferred or distributed. Local contact details: Adverse reactions or quality problems experienced with this product should be reported to the FDA and Medtronic: "Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) or call FDA (800) FDA-1088 "Call Medtronic at 800-448-3644, Option 3 An Update to URGENT: MEDICAL DEVICE RECALL notification letter dated 6/16/25 was sent to customers. Medtronic recently notified you of a voluntary recall of specific lots of the Bravo CF capsule delivery device. In the original notification letter sent on 03 June 2025 we separated impacted lot numbers by product number. Please note that the Lot numbers listed in Appendix A below can be found on both the 5-pk FGS-0635 outer label and on the 1-pk FGS-036 individual units. Customers should check the full list of Lot numbers listed in the appendices when inspecting inventory. A revised Appendix A is attached to this letter. If you have already completed product inspection and returned the Customer Confirmation form, please re-inspect your inventory against the full list of impacted Lot numbers and re-submit the form to: [email protected]
US Nationwide. Global Distribution.
128,202 units