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.
FDA Recall Z-2745-2011 · Posted 2011-07-06
Recalling FirmBarrx Medical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-05-25
Date Terminated2011-09-07
Product Quantity936 devices
Reason for Recall
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.