The Recall Desk

FDA (Devices) recall action 67400

Medtronic Inc. Cardiac Rhythm Disease Management recalled 6 products on 2014-02-26

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2014-02-26
Critical
0
Units
—

Why these products were recalled

Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

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

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-02-26

    Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.

    Product
    Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D Arterial Cannulae because the device body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wi
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified b
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to
    Category
    Distribution
    2 states