FDA Medical Device Recalls (openFDA)
Sanarus Medical Inc: Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
- Recall number
- Z-1008-03
- Recalling firm
- Sanarus Medical Inc
- Product
- Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
- Status
- Terminated
- Initiated
- 2003-06-16
- Posted
- 2003-07-15
- Terminated
- 2003-08-22
- Reason
- Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
- Root cause
- Other
- Action
- A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.
- Quantity
- 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.
- Lot, serial or model codes
- Lot # C030404
- 510(k) numbers
- ["K022314"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3003515897
- Firm city
- Pleasanton
- 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