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Recall company profile

Datascope Corporation Recalls

Overview of recall records associated with Datascope Corporation, including dates, categories and classifications where available.

20recall records

Nov 2, 2022latest record date

Feb 12, 2020earliest record date

Recall history in this database

Classification mix: Class II: 20.

Medical DeviceNov 2, 2022

Datascope LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. recall — FDA Z-0131-2023

The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or…

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 14, 2022

Datascope Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter recall — FDA Z-1687-2022

Certain lots containing undersized dilator.

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N recall — FDA Z-2839-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product recall — FDA Z-2842-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit recall — FDA Z-2843-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01 recall — FDA Z-2833-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N recall — FDA Z-2837-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N recall — FDA Z-2838-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N recall — FDA Z-2846-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N recall — FDA Z-2831-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N recall — FDA Z-2847-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N recall — FDA Z-2841-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N recall — FDA Z-2832-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N recall — FDA Z-2845-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N recall — FDA Z-2836-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit recall — FDA Z-2844-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N recall — FDA Z-2835-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N recall — FDA Z-2840-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceSep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N recall — FDA Z-2834-2020

Potential Endotoxin Contamination

Class IIFDA: OngoingDatascope Corporation

Medical DeviceFeb 12, 2020

Datascope Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310 recall — FDA Z-0934-2020

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

Class IIFDA: TerminatedDatascope Corporation

Understanding this recall history

This page summarizes recall records in which the official source identifies Datascope Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.