Retrograde Cardioplegia Cannula — Class II medical device recall Z-0068-2019
Terminated recall by Surge Medical Sales, LLC (DBA Surge Cardiovascular), reported 2018-10-10. The device was built with the rigid insertion stylet instead of the flexible stylet.
| Recall number | Z-0068-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Surge Medical Sales, LLC (DBA Surge Cardiovascular), Grand Rapids, MI, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2018-10-04 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2019-04-04 |
| Quantity | 35 units |
| Lot numbers | 00794-030718 |
| Model numbers | RMG-0015S |
Product
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Reason for recall
The device was built with the rigid insertion stylet instead of the flexible stylet.
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-0068-2019. 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.