FDA Enforcement
Class II
Terminated
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.
Recall: Z-2164-2017
·
Reported May 31, 2017
Enforcement
- Recall Number
- Z-2164-2017
- Event ID
- 76942
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Datascope Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 31, 2017
- Initiation Date
- April 12, 2017
- Classification Date
- May 25, 2017
- Termination Date
- January 28, 2020
- Address
- 15 Law Dr, Fairfield, NJ, 07004-3206, United States
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
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 Info
300004515, 3000043376 3000040272 3000038372 added lot numbers: 3000043374 and 3000045513
Distribution
Nationwide
Quantity
996 UNITS