Base for Terumo Advanced Perfusion System 1 — Class II medical device recall Z-1688-2015
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2015-06-03, distributed nationwide. Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1
| Recall number | Z-1688-2015 |
|---|---|
| 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 | 2015-05-01 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2018-09-28 |
| 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 | 801764 |
Product
Base for Terumo Advanced Perfusion System 1, 220/240V 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.
Reason for recall
Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protector to the On/Off power switch to preven
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-1688-2015. 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.