The Recall Desk

FDA (Devices) recall action 65342

Medtronic Neuromodulation recalled 4 products on 2013-07-03

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2013-07-03
Critical
0
Units
1,504,588

Why these products were recalled

The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

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.

1–4 of 4

  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls INDURA 1P Intrathecal Catheters Due to Occlusion Risk

    Medtronic is recalling INDURA 1P Intrathecal Catheters because the previous connector design has a greater potential for misalignment and occlusion.

    Product
    Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors. Conte
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls Sutureless Connector Intrathecal Catheters Due to Occlusion Risk

    Medtronic is recalling 115,722 Sutureless Connector Intrathecal Catheters worldwide because the previous design has a greater potential for misalignment and occlusion.

    Product
    Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package
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    0 states
  • HighFDA (Devices)··2013-07-03

    Medtronic Sutureless Pump Connector Revision Kit Recalled for Occlusion Risk

    Medtronic is recalling Sutureless Pump Connector Revision Kits due to a design flaw that increases the risk of catheter occlusion.

    Product
    Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package
    Category
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    0 states
  • HighFDA (Devices)··2013-07-03

    Medtronic Recalls Intrathecal Catheter Pump Segment Revision Kits

    Medtronic is recalling unused Model 8596SC Pump Segment Revision Kits due to a design flaw that increases the risk of catheter occlusion.

    Product
    Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The
    Category
    Distribution
    0 states