Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm… recallZ-3092-2011 · Covidien, PLC · initiated Feb 6, 2009
Terminated All recalls posted in August 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien, PLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Generator may deliver full power when a lower power is selected.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-3092-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 6, 2009
- Posted by the FDA
- Aug 30, 2011
- Recalling firm
- Covidien, PLC
- Quantity
- 357 units
- Product code
- GEI
- FDA submissions
- K011676
- 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 description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K011676 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Evident VTGENCovidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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