Coronary Artery Perfusion Cannula with Balloon — Class II medical device recall Z-2757-2016
Terminated recall by Sorin Group USA, Inc., reported 2016-09-14, distributed in IL, MO, TX. The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the
| Recall number | Z-2757-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2016-08-12 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-03-27 |
| Distributed | IL, MO, TX |
| Countries outside the US | CA, IT |
| Quantity | 1,205 units |
| Lot numbers | 1425900137, 1433900079, 1433900080, 1435300088 |
| Model numbers | CP-2200X |
Product
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
Reason for recall
The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
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-2757-2016. 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.