The Recall Desk

FDA (Devices) recall action 93919

Medtronic Neurosurgery recalled 5 products on 2024-03-06

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2024-03-06
Critical
0
Units
89,094

Why these products were recalled

Potential for catheter disconnection from the patient line stopcock connectors.

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.

States named across these recalls

1–5 of 5

  • SevereFDA (Devices)··2024-03-06

    Medtronic Duet External Drainage System catheter disconnection risk recalled

    Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2024-03-06

    Medtronic Duet Catheter System Recalled for Potential Disconnection Risk

    Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2024-03-06

    Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk

    Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2024-03-06

    Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk

    Medtronic is recalling 30,711 units of its Duet External Drainage System because of the potential for catheter disconnection from patient line stopcock connectors.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2024-03-06

    Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk

    Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Distribution
    50 states