The Recall Desk

FDA (Devices) recall action 65381

Terumo Cardiovascular Systems Corporation recalled 2 products on 2013-08-21

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
2013-08-21
Critical
0
Units
3,314

Why these products were recalled

Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.

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

  • ModerateFDA (Devices)··2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Pump Service Error

    Terumo is recalling Advanced Perfusion System 1 units because user-induced movement may trigger a false 'Service Pump' error message, potentially causing unnecessary service delays.

    Product
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when use
    Category
    Distribution
    44 states
  • ModerateFDA (Devices)··2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Service Pump Error Messages

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because user-induced motor movement can trigger a false 'Service Pump' error message, potentially misleading operators.

    Product
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures
    Category
    Distribution
    44 states