The Sarns TCM II — Class II medical device recall Z-1791-2021
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2021-06-09. Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectat
| Recall number | Z-1791-2021 |
|---|---|
| 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 | 2021-04-16 |
| Classified | 2021-06-04 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-11-29 |
| Countries outside the US | AE, AU, BE, CA, CH, CL, CN, CO, DE, DO, ES, FR, GB, GR, HK, ID, IL, IN, IR, IT, JP, KR, MX, MY, NL, NO, NZ, PH, RU, SA, SE, SG, TH, TR, TW, VN |
| Quantity | 995 devices |
| Model numbers | 15747, 164925, 164930, 164935, 4415 |
Product
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747
Reason for recall
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
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-1791-2021. 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.