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Datascope Corp. recall records

53 reported ongoing

53 records in this archive. Latest source date Feb 6, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 the left battery bay limits full inser...

Class IIIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway.

Official source
FDA device enforcement

CS100 IABP. Software Version CS100 IABP Q.01.

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Bel...

Official source
FDA device enforcement

CS300 IABP. Software Version CS300 IABP C.01.

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Bel...

Official source
FDA device enforcement

Cardiosave Hybrid. 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.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herze...

Official source
FDA device enforcement

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.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herze...

Official source
FDA device enforcement

Cardiosave Hybrid

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

Class IIIReported ongoing

Distribution: Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgiu...

Official source
FDA device enforcement

Cardiosave Rescue

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

Class IIIReported ongoing

Distribution: Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgiu...

Official source
FDA device enforcement

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.

Class IIReported ongoing

Distribution: International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Swede...

Official source
FDA device enforcement

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 Cardiosave Rescue Intra-Aortic Balloon Pum...

Class IReported ongoing

Distribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOM...

Official source
FDA device enforcement

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.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 Pum...

Class IReported ongoing

Distribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOM...

Official source
FDA device enforcement

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.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 Cardiosave Rescue Intra-Aortic Balloon...

Class IReported ongoing

Distribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOM...

Official source
FDA device enforcement

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 Cardiosave Rescue Intra-Aortic Balloon...

Class IReported ongoing

Distribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOM...

Official source
FDA device enforcement

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0...

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(...

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source
FDA device enforcement

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

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(...

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source
FDA device enforcement

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0...

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

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source
FDA device enforcement

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

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

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source
FDA device enforcement

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0...

Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IF...

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source
FDA device enforcement

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IF...

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source

Reasons in these listed records

  • 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 the left battery bay limits full insertion of certain batt...
  • The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
  • The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
  • The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

These examples come from this result page and are not a ranking of every recall reason.

Checking Datascope Corp.

Is there a recall on datascope corp. right now?

This archive contains 53 records, including 53 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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