Reported Sep 19, 2012 · Terminated
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse).…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
- Interfaces subject to recallMedtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse)
- LABELINGBox
- LabelREF 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
- Lot codes and dates
8253210 (Pulse). Serial Numbers 00004000090001000013000140001500017 (International Consignees only)
- Amount recalled
- 7
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Xomed, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.