System 1 base 100/120V The Terumo Advanced Perfusion System 1 is… — Class II medical device recall Z-2177-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-08-15, distributed nationwide. Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-
| Recall number | Z-2177-2012 |
|---|---|
| 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 | 2012-07-26 |
| Classified | 2012-08-09 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2012-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, CA, CL, CO, CR, DE, DO, EG, GT, HK, HN, ID, IN, 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, 1109-1450, 1452 |
| Model numbers | 801763 |
Product
System 1 base 100/120V The Terumo Advanced Perfusion System 1 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 sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re
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-2177-2012. 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.