Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage:… — Class II medical device recall Z-2443-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-10-03, distributed nationwide. Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advance
| Recall number | Z-2443-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2012-09-10 |
| Classified | 2012-09-23 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 150 units |
| Serial numbers | 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, 00823-00847 |
| Model numbers | 802018 |
Product
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD 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 used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Reason for recall
Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unli
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.