Device 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.
Z-0068-2019
Product summary
- Event
- Event 81042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-0068-2019
Official wording
Reason: The device was built with the rigid insertion stylet instead of the flexible stylet.
Code information: Lot code: 00794-030718
Distribution pattern: US Distribution to state of: SC.
Derived failure modes
-
Unknown
The device was built with the rigid insertion stylet instead of the flexible stylet.