Custom Cardiovascular Procedure Kits — Class II medical device recall Z-1828-2015
Terminated recall by Terumo Cardiovascular Systems Corp, reported 2015-07-01, distributed in FL, MO. The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracopor
| Recall number | Z-1828-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corp, Ashland, MA, United States |
| Recall initiated | 2015-05-06 |
| Classified | 2015-06-22 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2015-07-27 |
| Distributed | FL, MO |
| Quantity | 163 devices |
| Reason classes | unapproved product |
| Lot numbers | QG17, QL09, RD03, RG09, RH07, RL15, RM20 |
| Model numbers | 66086-01, 70700-03 |
Product
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Reason for recall
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
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-1828-2015. 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.