FDA Device recall Z-2449-2012
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional pe…
- FDA Device
- Class II
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class II recall of Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional pe… by Terumo Cardiovascular Systems, citing 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 Mo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2449-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-20 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
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
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
Identifiers
| code_info | Catalog number: 802018 and serial numbers: 00122,00132, 00137, 00321-00337, 00339, 00340, 00342-00389,00391-00439, 0044…Catalog number: 802018 and serial numbers: 00122,00132, 00137, 00321-00337, 00339, 00340, 00342-00389,00391-00439, 00441, 00442, 00444-00455, 00457, 00459, 00460, 00466, 00467, 00475, and 00488. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2449-2012%22
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