Datascope Corp. recalls Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Read the official notice →- Date
- 2025-12-24
- Country
- United States
- Brand
- Datascope
- Product
- Cardiosave Rescue
- Classification
- Class III
- Units
- Domestic: Nationwide distribution. International: Albania, Algeria, Angola,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Datascope recalls
- 2026-03-25
USDatascope Corp. recalls Battery Charging Station; Model: 0998-00-0802;
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in…
FDA · DeviceDatascope Corp.Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN,…Official notice →- 2026-03-11
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The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
FDA · DeviceDatascope Corp.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2025-12-17
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Datascope Corp. recalls Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
FDA · DeviceDatascope Corp.Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola,…Official notice → - 2024-11-13
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Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
There is discrepant labeling on the inner and outer packaging of the device.
FDA · DeviceDatascope Corp.International distribution to the countries of Germany, Spain , Finland, Great…Official notice → - 2024-10-02
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Datascope Corp. recalls CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Firm has developed a software correction (Revision D.01) for 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…
FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice → - US
Datascope Corp. recalls CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
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…
FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice →
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