Terumo Advanced Perfusion System 1 Flow Module indicated for use in… — Class II medical device recall Z-2449-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-10-03, distributed nationwide. Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion Sys
| Recall number | Z-2449-2012 |
|---|---|
| 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 | 2012-09-20 |
| Classified | 2012-09-25 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, DE, JO, JP, MX, RU, SA, SG, VN |
| Quantity | 72 units |
| Reason classes | device malfunction |
| Serial numbers | 00122, 00132, 00137, 00321-00337, 00339, 00340, 00342-00389, 00391-00439, 00441, 00442, 00444-00455, 00457, 00459, 00460, 00466, 00467, 00475, 00488 |
| Model numbers | 802018 |
Product
Terumo Advanced Perfusion System 1 Flow Module 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
Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat
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-2449-2012. 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.