Medtronic TRILLIUM AFFINITY NT — Class II medical device recall Z-0646-2018
Terminated recall by Medtronic Perfusion Systems, reported 2018-02-28. Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated a
| Recall number | Z-0646-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2018-01-16 |
| Classified | 2018-02-20 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-08-21 |
| Countries outside the US | AU, CA, CO, DE, DK, GB, GY, IL, IT, JP, NL, NO, SA |
| Quantity | 3,864 units |
| Reason classes | sterility |
Product
Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
Reason for recall
Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
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-0646-2018. 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.