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

FDA device recall Z-2745-2011 · posted 2011-07-06 · Terminated

Recall details

Recalling firm

Barrx Medical, Inc.

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.

Action taken

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

Status

Terminated

Product code

GEI

Quantity affected

936 devices

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China

Date initiated

2011-05-25

Date posted

2011-07-06

Date terminated

2011-09-07

Location

Sunnyvale, CA

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