The Recall Desk

FDA (Devices) recall action 66882

Medtronic Neurosurgery recalled 3 products on 2013-12-04

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
2013-12-04
Critical
0
Units
39

Why these products were recalled

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

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

  • ModerateFDA (Devices)··2013-12-04

    Medtronic Recalls Strata II Shunt Kits Due to Label Discrepancies

    Medtronic Neurosurgery is recalling Strata II Shunt Assembly Kits and other CSF shunts because of label discrepancies. The recall affects 5 units distributed worldwide.

    Product
    Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
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    Distribution
    0 states
  • ModerateFDA (Devices)··2013-12-04

    Medtronic Recalls Delta Shunt Assembly Kits Due to Label Discrepancies

    Medtronic Neurosurgery is recalling Delta Shunt Assembly Kits because label discrepancies were found. The recall covers 34 units distributed worldwide.

    Product
    Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.
    Category
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    0 states
  • ModerateFDA (Devices)··2013-12-04

    Medtronic Recalls CSF-Unitized Shunts Due to Label Discrepancies

    Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits due to label discrepancies.

    Product
    CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated…
    Category
    Distribution
    0 states