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U.S. Department of Health and Human Services

Class 1 Device Recall Bravo CF

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 Class 1 Device Recall Bravo CFsee related information
Date Initiated by FirmAugust 06, 2026
Date PostedSeptember 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3090-2026
Recall Event ID 99626
Product Classification Electrode, pH, stomach - Product Code FFT
ProductBravo 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 Information 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)
FEI Number 3003348376
Recalling Firm/
Manufacturer		 Given Imaging Ltd.
New Industrial Park
2, Hacarmel St.; Ta Do'Ar 258
Yokne'Am Ilit Israel
For Additional Information ContactSabrina Zimring
720-7743454
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce127,416
DistributionWorldwide 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.
Total Product Life CycleTPLC 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.
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