The Recall Desk

FDA (Devices) recall action 63543

Terumo Cardiovascular Systems Corporation recalled 2 products on 2012-12-05

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
2012-12-05
Critical
0
Units
3,294

Why these products were recalled

Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limi

Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be

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

  • SevereFDA (Devices)··2012-12-05

    Terumo Advanced Perfusion System 1 Recalled for Total Loss of Functionality

    Terumo is recalling 1,647 Advanced Perfusion System 1 units because they may shut down completely, stopping pumps and failing to activate battery backup.

    Product
    100/120V AC, Advanced Perfusion System Platform (APS) 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 qua
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2012-12-05

    Terumo Advanced Perfusion System 1 Recalled for Power Loss

    Terumo is recalling Advanced Perfusion System 1 units that may lose power and shut down during use, causing pumps to stop.

    Product
    220/240V AC, Advanced Perfusion System Platform (APS) 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 qua
    Category
    Distribution
    45 states