VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic… recallZ-0947-2009 · Medtronic Xomed, Inc. · initiated Nov 21, 2008
Terminated All recalls posted in March 2009
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 Medtronic Xomed, Inc. 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
Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.
FDA root cause category: Employee error
What the company is doing
All consignees were contacted by telephone (initiated on November 10, 2008). After telephone contact, each consignee was sent a follow-up fax/letter, "Urgent Product Recall Notification". The letter described the issue and actions for customers to take in response to the recall. Customers were instructed to check their inventories and return affected product to Medtronic Xomed, Inc. Customers were also instructed to fax their completed "Customer Contact and Product Return Checklist" to Medtronic Xomed, Inc. at 1-904-296-2386. Direct questions to Medtronic ENT Customer Service at 1-800-874-5797 (select Option 1 for Customer Service) and ask for the Vari-Stim Field Action Contact Person.
Recall details
- Recall number
- Z-0947-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 21, 2008
- Posted by the FDA
- Mar 3, 2009
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 22 boxes (220 units)
- Product code
- ETN
- FDA submissions
- K031003
- Distribution
- Worldwide Distribution --- including USA and country of Canada. (22 boxes were distributed within U.S. Three boxes were distributed to Medtronic Canada but returned)
Product description
VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to stimulate motor nerves exposed during surgery for the purpose of identification or location.
Code information (models, lots, serial numbers)
Lot Number 58536200.
Other devices under the same FDA submission
2 devices cleared under K031003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- N/A 9450003Medtronic Sofamor Danek, Inc. · STIMULATOR, NERVE1 report
- N/A 9450020Medtronic Sofamor Danek, Inc. · STIMULATOR, NERVE1 report
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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