Device 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.
Z-2757-2016
Product summary
- Event
- Event 74934
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1205 units worldwide
- Official record key
device-enforcement:Z-2757-2016
Official wording
Reason: 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.
Code information: Lot Numbers: 1425900137, 1433900079, 1433900080, 1435300088.
Distribution pattern: Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
Derived failure modes
-
Unknown
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.