Z-2745-2011

HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories...

Name: Z-2745-2011 HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories...
Creator: Barrx Medical, Inc.
Published: 2011-05-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-05-25 / Terminated / root cause: design

FDA source

Barrx Medical, Inc. began a recall of 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... on 2011-05-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2745-2011
Status: Terminated
Initiated: 2011-05-25
Posted: 2011-07-06
Terminated: 2011-09-07
Recalling firm: Medtronic, 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: design
FDA 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 in commerce: 936 devices
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China
Product codes and lots: 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.

Product code GEI

K101111Class IIHalo Ablation Catheter Model 90-9100, Halo90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc. / cleared 2010-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)