The Recall Desk

FDA (Devices) recall action 63008

Medtronic Xomed, Inc. recalled 3 products on 2012-09-19

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-09-19
Critical
0
Units
524

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2012-09-19

    Medtronic Recalls NIM 3.0 Patient Interfaces Due to Signal Loss

    Medtronic Xomed is recalling seven NIM 3.0 Patient Interfaces because they may fail to detect electrode signal loss, potentially delaying surgical procedures.

    Product
    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 US
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-19

    Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss

    Medtronic is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss and potential surgical delays.

    Product
    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA*
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-19

    Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss

    Medtronic Xomed is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss from the electrode.

    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 US
    Category
    Distribution
    0 states