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

Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.

FDA Recall Z-3092-2011 · Posted 2011-08-30

Recalling FirmCovidien, PLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-02-06
Date Terminated2011-08-30
Product Quantity357 units

Reason for Recall

Generator may deliver full power when a lower power is selected.

Firm Action

Covidien sales reps began notifying affected customers on February 6, 2009, followed by a letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the affected product to: Covidien Energy Based Devices 5920 Longbow Road Boulder, Colorado 80301 Customers were asked to label the exterior of the carton with their Return Authorization number. Covidien EbD would address the issue and return the unit to them. For any questions customers were asked to call Covidien EbD's Service Department toll-free at 1-800-255-8522, x 4923 or contact their local sales representative for additional information.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Switzerland, and the UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

↑