Recall Z-2164-2017
Datascope Corporation · initiated April 12, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 300004515, 3000043376 3000040272 3000038372 added lot numbers: 3000043374 and 3000045513
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
Getinge notified their customers with a recall letter/return response form via Fed Ex on 4/12/2017. Getinge notified their customers again through an expansion on 10/16/2017.
Details
- Recall number
- Z-2164-2017
- Initiated
- April 12, 2017
- Terminated
- January 28, 2020
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 996 UNITS
- Distribution
- Nationwide
- Recalling firm
- Datascope Corporation, Fairfield, NJ