FDA Medical Device Recalls (openFDA)
Barrx Medical, Inc.: Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
- Recall number
- Z-0192-2009
- Recalling firm
- Barrx Medical, Inc.
- Product
- Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
- Status
- Terminated
- Initiated
- 2008-09-18
- Posted
- 2008-10-31
- Terminated
- 2011-04-26
- Reason
- Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.
- Root cause
- Mixed-up of materials/components
- Action
- The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance.
- Quantity
- 650 units
- Distribution
- Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .
- Lot, serial or model codes
- Filter Lot number 78156 was packaged with Catheter Lot numbers: F1012714 , F1012715 , F1012716 , F1012718 , F1012721 , F1012723 , and F1012724, and/or with Sizing Balloon Lot number: F1012719.
- 510(k) numbers
- not on file
- 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