100/120V AC — Class II medical device recall Z-1977-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-08-21, distributed nationwide. TCVS is taking action to update the Operators Manual with the specific instructions to respond to this conditi
| Recall number | Z-1977-2013 |
|---|---|
| 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 | 2013-08-15 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, HK, ID, JP, KR, MX, MY, PH, SG, TH, TW |
| Quantity | 1,657 |
| Reason classes | labeling |
| Model numbers | 801763 |
Product
100/120V AC, Advanced Perfusion System 1 Product Usage: 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 TM or similar equipment.
Reason for recall
TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from 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-1977-2013. 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.