The Recall Desk

FDA (Devices) recall action 62373

Terumo Cardiovascular Systems Corporation recalled 2 products on 2012-07-18

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
2012-07-18
Critical
0
Units
1,640

Why these products were recalled

Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopu

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.

1–2 of 2

  • HighFDA (Devices)··2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump malfunctions that could require backup equipment during surgery.

    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 who
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 648 units of the Advanced Perfusion System 1 due to roller pump malfunctions that may require replacement with back-up equipment during procedures.

    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 who
    Category
    Distribution
    0 states