FDA Device recall Z-1964-2012
Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours…
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours… by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users expe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1964-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-22 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. 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. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
Reason
Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
Identifiers
| code_info | catalog number: 801764 and Serial numbers: 0006-0066, 0100-0311, 0313-0322,1001-1027,1100-1434,1436, 1440, and 1441. |
|---|
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-1964-2012%22
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