Terumo Advanced Perfusion System 1 — Class II medical device recall Z-2042-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-07-25, distributed nationwide. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System
| Recall number | Z-2042-2012 |
|---|---|
| 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 | 2012-06-18 |
| Classified | 2012-07-19 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BD, BE, BO, BR, CA, CH, CL, CN, CO, CR, DE, DK, DO, EC, EG, ES, FR, GT, HK, HN, ID, IL, IN, IT, JO, KR, KW, LB, LK, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, RU, SA, SE, SG, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 992 units |
| Reason classes | device malfunction |
| Serial numbers | 0011-1450 |
| Model numbers | 801763 |
Product
Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is 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 has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syste
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.