Sarns Modular Perfusion System 8000 base — Class II medical device recall Z-2048-2012
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-2048-2012 |
|---|---|
| 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 | 26 units |
| Reason classes | device malfunction |
| Serial numbers | 1001-1026 |
| Model numbers | 16409 |
Product
Sarns Modular Perfusion System 8000 base, 4 pump 100V. 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 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 (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
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.