The Recall Desk

FDA (Devices) recall action 61753

Terumo Cardiovascular Systems Corporation recalled 2 products on 2012-07-25

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-07-25
Critical
0
Units
1,640

Why these products were recalled

Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or

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

1–2 of 2

  • HighFDA (Devices)··2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Power Malfunction

    Terumo is recalling 992 Advanced Perfusion System 1 units due to a power loss error message that may affect system stability during medical procedures.

    Product
    System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Power Fluctuation Errors

    Terumo is recalling 648 Advanced Perfusion System 1 units due to a Red X error indicating loss or fluctuation of internal power on one side of the base.

    Product
    System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Distribution
    43 states