Recall Z-2164-2017 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
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.
| Date | Apr 12, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 996 UNITS |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES Datascope Corp., Dec 12, 2013 |