Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)

FDA Recall Z-1008-03 · Posted 2003-07-15

Recalling FirmSanarus Medical Inc
Recall StatusTerminated
Date Initiated2003-06-16
Date Terminated2003-08-22
Product Quantity41

Reason for Recall

Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

Firm Action

A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022314SANARUS VISICA TREATMENT SYSTEMSanarus Medical, Inc. · 2002-10-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑