Z-1008-03

Sanarus Visica Treatment System (disposable), Model/

Name: Z-1008-03 Sanarus Visica Treatment System (disposable), Model/
Creator: Sanarus Medical Inc
Published: 2003-06-16
License: https://open.fda.gov/license/

Sanarus Medical, Inc. / initiated 2003-06-16 / Terminated

FDA source

Sanarus Medical Inc began a recall of Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single) on 2003-06-16. The reason FDA records is "Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1008-03
Status: Terminated
Initiated: 2003-06-16
Posted: 2003-07-15
Terminated: 2003-08-22
Recalling firm: Sanarus Medical, Inc.
Product: Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
Reason for recall: Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
FDA root cause: Other
Action: A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.
Quantity in commerce: 41
Distribution: Product was released for distribution to 12 consignees across the United States, including US states: GA, WI, TX and NY. A total of 41 units from the lot had been shipped to these consignees. The recall was extended to the user level who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Product codes and lots: Lot # C030404

K022314Class IISanarus Visica Treatment SystemSanarus Medical, Inc. / cleared 2002-10-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)