Device product
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
Z-2164-2017
Product summary
- Event
- Event 76942
- Status
- Terminated
- Classification
- Class II
- Quantity
- 996 UNITS
- Official record key
device-enforcement:Z-2164-2017
Official wording
Reason: Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.
Code information: 300004515, 3000043376 3000040272 3000038372 added lot numbers: 3000043374 and 3000045513
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.