Datascope Corporation recalls

66 recalls on record · latest: August 5, 2022

Official U.S. recall history for Datascope Corporation, compiled from official government records.

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Datascope Corporation recalls MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

August 5, 2022 · Medical device recalls Moderate risk Certain lots containing undersized dilator.

Datascope Corporation recalls Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter

August 5, 2022 · Medical device recalls Moderate risk Certain lots containing undersized dilator.

Datascope Corporation recalls Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter

August 5, 2022 · Medical device recalls Moderate risk Certain lots containing undersized dilator.

Datascope Corporation recalls LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

August 5, 2022 · Medical device recalls Moderate risk The balloon volume is incorrectly described as 34cc instead of 40cc on one of t…

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-0…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acu…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Us…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-029…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U,…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-0…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage:…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Us…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-0…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684…

July 27, 2020 · Medical device recalls Moderate risk Potential Endotoxin Contamination

Datascope Corporation recalls Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous inse…

November 20, 2019 · Medical device recalls Moderate risk Potential for compromised sterility in breached pouches of specific lots of Rei…

Datascope Corporation recalls Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous i…

November 20, 2019 · Medical device recalls Moderate risk Potential for compromised sterility in breached pouches of specific lots of Rei…

Datascope Corporation recalls Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous in…

November 20, 2019 · Medical device recalls Moderate risk Potential for compromised sterility in breached pouches of specific lots of Rei…

Datascope Corporation recalls Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: T…

May 28, 2019 · Medical device recalls Moderate risk The device was distributed with the outer carton labeled with the manufacture d…

Datascope Corporation recalls Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used…

February 21, 2018 · Medical device recalls Moderate risk The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter…

Datascope Corporation recalls Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used…

February 21, 2018 · Medical device recalls Moderate risk The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter…

Datascope Corporation recalls Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used t…

February 21, 2018 · Medical device recalls Moderate risk The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter…