Terumo¿ Advanced Perfusion System 1 100/120V AC — Class II medical device recall Z-2018-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-07-16, distributed nationwide. An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related t
| Recall number | Z-2018-2014 |
|---|---|
| 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 | 2014-06-17 |
| Classified | 2014-07-08 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2014-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, HK, ID, JP, KR, MX, MY, PH, SG, TH, TW, VN |
| Quantity | 1,713 units |
| Model numbers | 801763 |
Product
Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Reason for recall
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
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-2018-2014. 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.