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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Barrx Medical, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Barrx Medical, Inc. is recalling Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, due to Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026