Terumo Advanced Perfusion System 1 System 1 Base — Class II medical device recall Z-1964-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-07-18, distributed nationwide. Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Ad
| Recall number | Z-1964-2012 |
|---|---|
| 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 | 2012-06-22 |
| Classified | 2012-07-09 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BE, CA, CL, CO, CR, DE, DO, EG, GT, HK, HN, ID, IL, IN, JO, JP, KR, KW, MX, MY, PH, PK, RU, SA, SG, TH, TR, TW, VN, ZA |
| Quantity | 992 units |
| Serial numbers | 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436, 1440, 1441 |
| Model numbers | 801764 |
Product
Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. 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 qualified medical professional who is experienced in the operation of this or similar equipment. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
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.