The Recall Desk

FDA (Devices) recall action 77641

Medtronic Perfusion Systems recalled 5 products on 2017-08-02

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
2017-08-02
Critical
0
Units
—

Why these products were recalled

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

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

1–5 of 5

  • ModerateFDA (Devices)··2017-08-02

    Medtronic DLP Antegrade/Retrograde Adapter Recalled for Packaging Pinholes

    Medtronic is recalling DLP Antegrade/Retrograde Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-08-02

    Medtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets because small pinholes were found in the sterile packaging.

    Product
    DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-08-02

    Medtronic Recalls DLP Pressure Monitoring Extension Line Adapters

    Medtronic Perfusion Systems is recalling DLP Pressure Monitoring Extension Line Adapters due to small pinholes in sterile packaging.

    Product
    DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-08-02

    Medtronic Recalls DLP Cardioplegia Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Cardioplegia Adapters with Pressure Port because small pinholes were identified in a single packaging configuration of sterile pouches.

    Product
    DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitori
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-08-02

    Medtronic Recalls DLP Extension Line Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Extension Line Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
    Category
    Distribution
    0 states