Z-0192-2009

Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22...

Name: Z-0192-2009 Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22...
Creator: Barrx Medical, Inc.
Published: 2008-09-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-09-18 / Terminated

FDA source

Barrx Medical, Inc. began a recall of 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... on 2008-09-18. The reason FDA records is "Some units may contain the wrong filter, which does not have the proper lock and may result in a leak". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0192-2009
Status: Terminated
Initiated: 2008-09-18
Posted: 2008-10-31
Terminated: 2011-04-26
Recalling firm: Medtronic, 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.
FDA 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 in commerce: 650 units
Distribution: Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .
Product codes and lots: 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.

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)