Perfusion System 8000 — Class II medical device recall Z-0130-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-10-31, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of
| Recall number | Z-0130-2013 |
|---|---|
| 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 | 2012-10-24 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2015-08-21 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AU, BD, BE, BO, BR, CA, CH, CL, CN, CO, CR, DE, DK, DO, EC, EG, ES, FR, HK, ID, IN, IT, JP, KR, LB, LK, MX, MY, NI, NZ, PA, PE, PH, PK, SA, SG, TH, TW, UY, VE, VN, ZA |
| Quantity | 26 units |
| Reason classes | device malfunction |
| Serial numbers | 1001-1026 |
| Model numbers | 16409 |
Product
Perfusion System 8000, base 4 pump, 100V 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 power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction
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-0130-2013. 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.