Z-3092-2011

Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP...

Name: Z-3092-2011 Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP...
Creator: Covidien, PLC
Published: 2009-02-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-02-06 / Terminated / root cause: design

FDA source

Covidien, PLC began a recall of 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... on 2009-02-06. The reason FDA records is "Generator may deliver full power when a lower power is selected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3092-2011
Status: Terminated
Initiated: 2009-02-06
Posted: 2011-08-30
Terminated: 2011-08-30
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Generator may deliver full power when a lower power is selected.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 357 units
Distribution: 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.
Product codes and lots: Serial Numbers: XP7K0101R to XP7K0120R, XP7L0121R to XP7L0140R, XP8B0141R to XP8B0167R, XP8C0168R to XP8C0231R, XP8D0232R to XP8D0320R, XP8E0321R to XP8E0390R, XP8F0391R to XP8F0485R, XP8H0578R to XP8H0615R, XP8I0626R to XP8I0660R, XP8J0661R to XP8J0690R, XP8L0701R to XP8L0730R.

Product code GEI

K011676Class IIVivawave Microwave SystemVivant Medical, Inc. / cleared 2002-06-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)