220/240V AC — Class II medical device recall Z-0436-2013

Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-12-05, distributed nationwide. Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss o

Recall number	`Z-0436-2013`
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	2012-11-14
Classified	2012-11-27
Reported by FDA	2012-12-05
Terminated	2013-08-30
Distributed	Nationwide (US)
Quantity	1,647 units
Serial numbers	`220/240VAC`
Model numbers	`801764`

Product

220/240V AC, Advanced Perfusion System Platform (APS) 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 Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be

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-0436-2013. 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.