Class II — Terumo Cardiovascular Systems Corporation
| Recalling firm | Terumo Cardiovascular Systems Corp. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react. |
| Product | Terumo® Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 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 used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment. |
| Quantity | 1657 |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada. |
| Initiated | 2013-07-26 |
| Classified | 2013-08-14 |
| Terminated | 2017-02-07 |
| Recall number | Z-1968-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo Cardiovascular Systems Corporation (Z-1968-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65354/
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