FDA Medical Device Recalls (openFDA)
Barrx Medical, Inc.: HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
- Recall number
- Z-2745-2011
- Recalling firm
- Barrx Medical, Inc.
- Product
- HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
- Status
- Terminated
- Initiated
- 2011-05-25
- Posted
- 2011-07-06
- Terminated
- 2011-09-07
- Reason
- Complaints of malfunction of the HALO ULTRA Ablation Catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.
- Root cause
- Component design/selection
- Action
- BARRX Medical, Inc. sent a "PRODUCT RECALL NOTIFICATION" letter dated May 25, 2011 via Federal Express to all of their customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the recalled product. BRRX Medical Territory Managers will be in contact with each facility and arrange for pick up of the recalled product. The "Steps for Voluntary Recall" form that is enclosed with each letter provides customers with complete instructions on segregating the product, completing the Tracking/Verification Form, obtaining Returned Good Authorization (RGA) number and preparing product for pick up. Customers are to complete and return the Tracking/Verification Form by fax to 408-738-1741 which should include amount of product on hand, contact name and hospital/distributor information. Questions should be directed to BRRX Medical Customer Service at 888-662-2779.
- Quantity
- 936 devices
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China
- Lot, serial or model codes
- Model number: 90-9200: Serial numbers: F1013145; Exp 4/30/2013; F1013152, Exp 4/30/2013; F1013176, Exp 5/31/2013; F1013184, Exp 6/30/2013; F1013214, Exp 7/31/2013; F1013228, Exp 7/31/2013; F1013246, Exp 8/31/2013; F1013264, Exp 9/30/2013; F1013312, Exp 12/31/2013; F1013356, Exp 2/28/2014; F1013365. Ex0 2/28/2014; F1013370, Exp 3/31/2014; F1013377, Exp 3/31/2014.
- 510(k) numbers
- ["K101111"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004904811
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28