Perfusion System 8000 — Class II medical device recall Z-0283-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-11-21, distributed nationwide. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of
| Recall number | Z-0283-2013 |
|---|---|
| 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 | 2012-09-25 |
| Classified | 2012-11-13 |
| Reported by FDA | 2012-11-21 |
| Terminated | 2013-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BR, CL, CO, DE, EC, ES, HK, ID, IN, JP, KR, LB, LK, MX, NZ, PE, SG, TH, TW, ZA |
| Quantity | 312 |
| Reason classes | device malfunction |
| Serial numbers | 1001-1004, 1007-1055, 1057-1310, 1648, 1649, 1657, 1822, 1823 |
| Model numbers | 16406 |
Product
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 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 Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardio
Machine access
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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.