FDA-Device2017-05-31Class II
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.
Datascope Corporation
Hazard
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.
Sold states
Nationwide
Affected count
996 UNITS
Manufactured in
15 Law Dr, Fairfield, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2164-2017Don't want to check this manually?
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