Class II — Terumo Cardiovascular Systems Corporation
| Recalling firm | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
|---|---|
| Registered facility | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. |
| Product | Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line |
| Quantity | 24,227. |
| Distribution | Nationwide Canada |
| Initiated | 2013-06-04 |
| Classified | 2013-12-27 |
| Terminated | 2014-10-01 |
| Recall number | Z-0603-2014 |
| 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-0603-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67064/
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