CLASS II Device recall · Reported 19 Sep 2012 · FDA Enforcement Report

Interfaces subject to recall: Medtronic NIM recalled by Medtronic Xomed

Medtronic Xomed is recalling Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient, distributed nationwide in the US. The recall was initiated on 27 Sep 2010 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes8253210 (Pulse). Serial Numbers 00004, 00009, 00010, 00013, 00014, 00015, 00017 (International Consignees only)

Quantity recalled7

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2344-2012
FDA event ID: 63008
Recalling firm: Medtronic Xomed, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 27 Sep 2010
FDA classified: 10 Sep 2012
Reported: 19 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

27 Sep 2010	Recall initiated by company
10 Sep 2012	Classified by FDA	+714 days
19 Sep 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

8253210 (Pulse). Serial Numbers 00004, 00009, 00010, 00013, 00014, 00015, 00017 (International Consignees only)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 63008

This product is part of a recall event; the main page for the event is Interfaces subject to recall: Medtronic NIM recalled by Medtronic Xomed.

Reported	Class	Recall	Company	Reason	Where
19 Sep 2012	CLASS II	Interfaces subject to recall: Medtronic NIM recalled by Medtronic Xomed	Medtronic Xomed	Device Malfunction	Nationwide
19 Sep 2012	CLASS II	Interfaces subject to recall: Medtronic NIM recalled by Medtronic Xomed	Medtronic Xomed	Device Malfunction	Nationwide

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