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Maquet Datascope Corp - Cardiac Assist Division

FDA Regulatory Profile

Summary

Total Recalls
14 (10 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0099-2019Class ICardiosave Hybrid IABP, Part Number 0998-00-0800-53September 20, 2018
Z-0100-2019Class ICardiosave Rescue IABP, Part Number 0998-UC-0800-83September 20, 2018
Z-1928-2018Class ICARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (eMay 3, 2018
Z-3087-2017Class ICS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary pJuly 17, 2017
Z-3085-2017Class ICS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary July 17, 2017
Z-3086-2017Class ICS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary pJuly 17, 2017
Z-2736-2017Class ICS 100i Intra-Aortic Balloon PumpJune 16, 2017
Z-2738-2017Class ICS 300 Intra-Aortic Balloon PumpJune 16, 2017
Z-2737-2017Class ICS 100 Intra-Aortic Balloon PumpJune 16, 2017
Z-1386-2017Class IICARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion December 23, 2016
Z-1248-2016Class IICardiosave Hybrid and rescue IABPDecember 16, 2015
Z-1140-2015Class IIMaquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)January 30, 2015
Z-1062-2015Class IICARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for December 16, 2014
Z-1523-2014Class IDatascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic BMarch 21, 2014