System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is… — Class II medical device recall Z-1968-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-07-18, distributed nationwide. Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions
| Recall number | Z-1968-2012 |
|---|---|
| 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 | 2012-06-25 |
| Classified | 2012-07-09 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2015-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, HK, HN, ID, IL, IN, JO, JP, KR, KW, MX, MY, PH, PK, RU, SA, SG, TH, TR, TW, VN, ZA |
| Quantity | 992 units |
| Reason classes | device malfunction |
| Serial numbers | 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, 1447-1450 |
| Model numbers | 801763 |
Product
System 1 Base 100/120V 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 Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is
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-1968-2012. 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.