Z-2343-2012Class II

Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410...

Name: Z-2343-2012 Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410...
Creator: Medtronic Xomed, Inc.
Published: 2010-09-27
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2010-09-27 / Terminated / root cause: design

FDA source

Medtronic Xomed, Inc. began a recall of Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410... on 2010-09-27. FDA classified it as Class II and gives the reason as "In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss...". 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-2343-2012
Classification: Class II
Status: Terminated
Initiated: 2010-09-27
Posted: 2012-09-10
Terminated: 2013-11-26
Recalling firm: Medtronic Xomed, Inc.
Product: Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Product code: GWF Stimulator, Electrical, Evoked Response
Reason for recall: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Medtronic USA, Inc., sent an "URGENT Product Recall Notification" letter dated September 27, 2010, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify their receipt of this notice and complete and sign the Product Replacement checklist form indicating that their sales representative has completed the replacement of their devices and fax to 1-651-367-8055. U.S. Customer Units - replacement kits with their contents will be provided to each Area Sales Manager (ASM) for each customer along with documentation of serial number units to be replaced. Each ASM will be responsible for delivering a replacement unit(s) and picking up and returning each of their customer's units using the pre-labeled replacement kit boxes. International Customer Units- International units, depending on the geography will either be replaced or repaired and returned. If replacement is planned, the International Business Manager (IBM) will receive replacement kits as described for the U.S. In those geographies where devices will be repaired and returned, kits with the following contents will be sent to IBM's along with documentation of serial number units to be repaired. Foreign distribution: In the larger territories (i.e. Australia, Japan, Canada, EMEA-Europe, Middle East, Africa), repairs/rework were handled at the Medtronic facilities in those geographic areas. In the smaller geographic areas (Singapore, Thailand, Hong Kong, Korea, Latin America ), where there were limited sales, devices were returned to the U.S. In all cases (large and small geographic areas), devices were returned via a Medtronic entity (sales office or distribution center). If you have any questions regarding the subject Actron or the content of this letter, contact the Distinguished Regulatory Affairs Advisor at 904-279-7532.
Quantity in commerce: 53
Distribution: Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: 8253410 (Neuro). All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2343-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2342-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10
Z-2343-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10
Z-2344-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10

Product code GWF

K083124Class IINim 3.0Medtronic Xomed, Inc. / cleared 2009-02-27

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)