Recall Z-2745-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
| Date | Jul 6, 2011 (initiated May 25, 2011) |
| Status | Terminated |
| 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 |
| Quantity | 936 devices |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101111 | HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 Barrx Medical, Inc., Jun 18, 2010 |