Z-2164-2017 Class II Terminated
FDA device recall Z-2164-2017 was initiated by Datascope Corporation on April 12, 2017 and is designated Class II. 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 pressu… The recall status is terminated (terminated January 28, 2020). Affected quantity: 996 UNITS.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- April 12, 2017
- Termination Date
- January 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 996 UNITS
Product Description
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.
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.
Distribution Pattern
Nationwide
Code Information
300004515, 3000043376 3000040272 3000038372 added lot numbers: 3000043374 and 3000045513