Terumo¿ Advanced Perfusion System 1: 220/240V AC — Class II medical device recall Z-1969-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-08-21, distributed nationwide. The operators manual does not fully describe the sequence of expected events that will occur when a specific o
| Recall number | Z-1969-2013 |
|---|---|
| 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 | 2013-07-26 |
| Classified | 2013-08-14 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, CN, HK, ID, JP, KR, MX, MY, SG, TH, TW |
| Quantity | 1,657 |
| Reason classes | labeling |
| Model numbers | 801764 |
Product
Terumo¿ Advanced Perfusion System 1: 220/240V 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1969-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.