Datascope Recalls
134 recalls on record · September 10, 2014 to March 25, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 6, 2021Medical DevicesFDA
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Hazard: The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
October 6, 2021Medical DevicesFDA
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-0
Hazard: The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
May 5, 2021Medical DevicesFDA
Datascope Corp. recalls Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support
Hazard: There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
May 5, 2021Medical DevicesFDA
Datascope Corp. recalls Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support
Hazard: There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
September 2, 2020Medical DevicesFDA
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 U
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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 U
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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 U
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usa
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usa
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acu
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: I
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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, 0684-00
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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, 0
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-0
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
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-
Hazard: Potential Endotoxin Contamination
September 2, 2020Medical DevicesFDA
Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-02
Hazard: Potential Endotoxin Contamination
February 12, 2020Medical DevicesFDA
Datascope Corporation recalls Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous inse
Hazard: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
February 12, 2020Medical DevicesFDA
Datascope Corporation recalls Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous in
Hazard: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
February 12, 2020Medical DevicesFDA
Datascope Corporation recalls Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous
Hazard: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
November 13, 2019Medical DevicesFDA
Datascope Corp. recalls Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IAB
Hazard: One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
July 24, 2019Medical DevicesFDA
Datascope Corporation recalls Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage:
Hazard: The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
July 24, 2019Medical DevicesFDA
Datascope Corp. recalls CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
Hazard: If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
July 24, 2019Medical DevicesFDA
Datascope Corp. recalls CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
Hazard: If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
July 24, 2019Medical DevicesFDA
Datascope Corp. recalls CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Hazard: If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
July 24, 2019Medical DevicesFDA
Datascope Corp. recalls CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
Hazard: If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.