Terumo 100/120V AC — Class II medical device recall Z-3242-2018
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2018-10-03, distributed nationwide. Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not tor
| Recall number | Z-3242-2018 |
|---|---|
| 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 | 2018-08-28 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, ID, IN, KR, MX, SG, VN |
| Quantity | 47 units |
| Serial numbers | 0386, 1481, 1497, 1509, 1526, 1529, 1531, 1532, 1535, 1536, 1537, 1538, 1539, 1540, 1541, 1542, 1543, 1544, 1545, 1546, 1547, 1548, 1549, 1550, 1551 and 24 more |
| Model numbers | 801763, 870509 |
Product
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Reason for recall
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system.
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-3242-2018. 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.