Z-0947-2009

VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve...

Name: Z-0947-2009 VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve...
Creator: Medtronic Xomed, Inc.
Published: 2008-11-21
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2008-11-21 / Terminated / root cause: manufacturing process

FDA source

Medtronic Xomed, Inc. began a recall of VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable... on 2008-11-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0947-2009
Status: Terminated
Initiated: 2008-11-21
Posted: 2009-03-03
Terminated: 2009-10-01
Recalling firm: Medtronic Xomed, Inc.
Product: 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.
Product code: ETN Stimulator, Nerve
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 22 boxes (220 units)
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 codes and lots: Lot Number 58536200.

Product code ETN

K031003Class IIStimulus/dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. / cleared 2003-04-11

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)