Class 1 Device Recall Bravo CF capsule delivery device

• Date Initiated by Firm: June 03, 2025
• Date Posted: July 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2047-2025
• Recall Event ID: 97029
• 510(K)Number: K102543
• Product Classification: Electrode, pH, stomach - Product Code FFT
• Product: 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)
• Code Information: FGS-0635: UDI-DI: 07290101369707; Lot Numbers: 61164F 61407F 61933F 62142F 62418F 62884F 63152F 63668F 64065F 64096F 64291F 61165F 61408F 61934F 62143F 62419F 62885F 63154F 63669F 64066F 64261F 64550F 61166F 61409F 61935F 62144F 62420F 62886F 63155F 63670F 64067F 64262F 64551F 61167F 61410F 61936F 62145F 62421F 62887F 63156F 63671F 64068F 64263F 64552F 61168F 61411F 61937F 62146F 62422F 62888F 63157F 63672F 64069F 64264F 64553F 61169F 61412F 61938F 62147F 62656F 62889F 63158F 63673F 64070F 64265F 64554F 61170F 61413F 61939F 62148F 62657F 62890F 63159F 63674F 64071F 64266F 64555F 61171F 61414F 61940F 62149F 62658F 62891F 63391F 63675F 64072F 64267F 64557F 61172F 61415F 62031F 62150F 62659F 62892F 63392F 63676F 64073F 64268F 64558F 61173F 61416F 62032F 62151F 62660F 62893F 63393F 63677F 64074F 64269F 64559F 61352F 61708F 62033F 62152F 62661F 62894F 63394F 63679F 64075F 64270F 64560F 61386F 61709F 62034F 62153F 62662F 62895F 63395F 63680F 64076F 64271F 64561F 61387F 61711F 62035F 62154F 62663F 62896F 63396F 63681F 64077F 64272F 64563F 61388F 61712F 62036F 62155F 62664F 62897F 63397F 63682F 64078F 64273F 64564F 61389F 61713F 62037F 62156F 62665F 63135F 63398F 63683F 64079F 64274F 64825F 61390F 61714F 62038F 62157F 62666F 63136F 63399F 63684F 64080F 64275F 64826F 61391F 61715F 62039F 62158F 62667F 63137F 63400F 63879F 64081F 64276F 64827F 61392F 61716F 62040F 62159F 62668F 63138F 63401F 63880F 64082F 64277F 64831F 61393F 61717F 62041F 62160F 62669F 63139F 63402F 63881F 64083F 64278F 65088F 61394F 61718F 62042F 62161F 62670F 63140F 63403F 63882F 64084F 64279F 65094F 61395F 61719F 62130F 62407F 62671F 63141F 63404F 63883F 64085F 64280F 61396F 61720F 62131F 62408F 62672F 63142F 63405F 63884F 64086F 64281F 61397F 61721F 62132F 62409F 62673F 63143F 63406F 63885F 64087F 64282F 61398F 61722F 62133F 62410F 62674F 63144F 63407F 63886F 64088F 64283F 61400F 61723F 62134F 62411F 62877F 63145F 63408F 63887F 64089F 64284F 61401F 61724F 62135F 62412F 62878F 63146F 63409F 63888F 64090F 64285F 61402F 61928F 62136F 62413F 62879F 63147F 63410F 63889F 64091F 64286F 61403F 61929F 62137F 62414F 62880F 63148F 63411F 63890F 64092F 64287F 61404F 61930F 62138F 62415F 62881F 63149F 63412F 63891F 64093F 64288F 61405F 61931F 62139F 62416F 62882F 63150F 63413F 63892F 64094F 64289F 61406F 61932F 62141F 62417F 62883F 63151F 63414F 64064F 64095F 64290F; FGS-0636: UDI-DI: 07290101369714, Lot Numbers: 61353F 61354F 61399F 61710F 62032F 62042F 62140F 62419F 62669F 62885F 63153F 63415F 63678F 65088F
• FEI Number: 3003348376
• Recalling Firm/ Manufacturer: Given Imaging Ltd.; New Industrial Park, POB 258; 2 Hacarmel St.; Yokne'Am Ilit Israel
• For Additional Information Contact: Sabrina Zimring; 720-774-3454
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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: rs.gmbmitgfca@medtronic.com
• Quantity in Commerce: 128,202 units
• Distribution: US Nationwide. Global Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FFT