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Barrx Medical, Inc.

United StatesFDA applicant, unverified

Devices
3
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Barrx Medical, Inc. makes

Barrx Medical, Inc. manufactures ablation catheters designed for cardiac procedures, including the HALO90 ULTRA, HALO90, and HALO60 models. These devices are intended for radiofrequency ablation to treat arrhythmias by creating precise lesions in heart tissue. The product line includes variations tailored for different anatomical applications and procedural needs.

The company’s ablation catheters fall under Class II medical devices in the US regulatory framework, requiring 510(k) clearance through the FDA. These devices are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution. The manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Barrx Medical, Inc., the earliest on 2008-09-18 and the most recent on 2011-05-25. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2011

    • 25 May 2011 Z-2745-2011 Unclassified (pre-2012) Terminated 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. Distribution: Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China Submission number: K101111

  • 2008

    • 18 Sep 2008 Z-0192-2009 Unclassified (pre-2012) Terminated Some units may contain the wrong filter, which does not have the proper lock and may result in a leak. Distribution: Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden,…
      Full distribution text Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .

Frequently asked questions

How many devices does Barrx Medical, Inc. have in the registry?

The registry currently lists 3 devices for Barrx Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Barrx Medical, Inc.'s devices?

Among its 3 most recently registered devices, Barrx Medical, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Barrx Medical, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Barrx Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Barrx Medical, Inc.?

FDA recall records list 2 recalls initiated by Barrx Medical, Inc., the most recent initiated on 25 May 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Barrx Medical, Inc. in the registry?

The most recently registered devices listed for Barrx Medical, Inc. include HALO90 ULTRA ABLATION CATHETER, HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 and HALO60 ABLATION CATHETER.

Generated automatically from registry data and not verified by a human reviewer.