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Datascope Corp.

Datascope Corp. Recalls

All product recalls associated with Datascope Corp..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 84 recalls

Cardiosave Rescue. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

FDANov 4, 2025Nationwide• Datascope Corp.

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

FDANov 4, 2025Nationwide• Datascope Corp.

Cardiosave Hybrid (Datascope) – IFU Vibration Standards Update (2025)

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

FDAOct 23, 2025

12 3...5

Page 1 of 5Next

Nationwide

• Datascope Corp.

Cardiosave Rescue (Datascope) – IFU Vibration Standards Update (2025)

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

FDAOct 23, 2025Nationwide• Datascope Corp.

MEGA Intra-Aortic Balloon (Datascope) – Packaging Labeling Discrepancy (2024)

There is discrepant labeling on the inner and outer packaging of the device.

FDASep 17, 2024Nationwide• Datascope Corp.

CardioSave Rescue Balloon Pump (Datascope) - Software Correction (2024)

Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

FDAAug 8, 2024Nationwide• Datascope Corp.

CardioSave Hybrid Balloon Pump (Datascope) - Software Correction (2024)

FDAAug 8, 2024Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

Users were identifying autofill failure conditions on the devices causing pump stops.

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Users were identifying autofill failure conditions on the devices causing pump stops.

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

FDAJul 31, 2023Nationwide• Datascope Corp.

Datascope Corp.: MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Access...

During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

FDAJun 23, 2023Nationwide• Datascope Corp.

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Datascope Corp. Recalls

Recall Summary

Cardiosave Rescue. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

Cardiosave Hybrid (Datascope) – IFU Vibration Standards Update (2025)

Cardiosave Rescue (Datascope) – IFU Vibration Standards Update (2025)

MEGA Intra-Aortic Balloon (Datascope) – Packaging Labeling Discrepancy (2024)

CardioSave Rescue Balloon Pump (Datascope) - Software Correction (2024)

CardioSave Hybrid Balloon Pump (Datascope) - Software Correction (2024)

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part...

Datascope Corp.: MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Access...

Datascope Corp.: YAMATO PLUS IAB; intra-aortic balloon catheter and access...

Datascope Corp.: MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessor...

Datascope Corp.: SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Ac...

Datascope Corp.: SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter an...