--- title: "Datascope Corp. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Datascope Corp. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/datascope-corp/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 6, 2026 FDA device enforcement ### [Battery Charging Station; Model: 0998-00-0802;](https://isitonrecall.com/recall/fda-device-z-1587-2026-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 III Reported 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 for Battery Charging Station; Model: 0998-00-0802;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1587-2026%22) Jan 23, 2026 FDA device enforcement ### [CS100 IABP. Software Version CS100 IABP Q.01.](https://isitonrecall.com/recall/fda-device-z-1486-2026-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 II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Bel... [Official source for CS100 IABP. Software Version CS100 IABP Q.01.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1486-2026%22) Jan 23, 2026 FDA device enforcement ### [CS300 IABP. Software Version CS300 IABP C.01.](https://isitonrecall.com/recall/fda-device-z-1487-2026-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 II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Bel... [Official source for CS300 IABP. Software Version CS300 IABP C.01.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1487-2026%22) Nov 4, 2025 FDA device enforcement ### [Cardiosave Hybrid. Intra-Aortic Balloon Pump system.](https://isitonrecall.com/recall/fda-device-z-0916-2026-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 II Reported ongoing Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herze... [Official source for Cardiosave Hybrid. Intra-Aortic Balloon Pump system.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0916-2026%22) Nov 4, 2025 FDA device enforcement ### [Cardiosave Rescue. Intra-Aortic Balloon Pump system.](https://isitonrecall.com/recall/fda-device-z-0917-2026-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 II Reported ongoing Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herze... [Official source for Cardiosave Rescue. Intra-Aortic Balloon Pump system.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0917-2026%22) Oct 23, 2025 FDA device enforcement ### [Cardiosave Hybrid](https://isitonrecall.com/recall/fda-device-z-0931-2026-cardiosave-hybrid/) The IFU addendum updates the Vibration and Shock Table to reference the correct standards. Class III Reported ongoing Distribution: Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgiu... [Official source for Cardiosave Hybrid](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0931-2026%22) Oct 23, 2025 FDA device enforcement ### [Cardiosave Rescue](https://isitonrecall.com/recall/fda-device-z-0932-2026-cardiosave-rescue/) The IFU addendum updates the Vibration and Shock Table to reference the correct standards. Class III Reported ongoing Distribution: Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgiu... [Official source for Cardiosave Rescue](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0932-2026%22) Sep 17, 2024 FDA device enforcement ### [MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01](https://isitonrecall.com/recall/fda-device-z-0311-2025-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 II Reported 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 for MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0311-2025%22) Aug 8, 2024 FDA device enforcement ### [CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.](https://isitonrecall.com/recall/fda-device-z-3134-2024-cardiosave-hybrid-intra-aortic-balloon-pump-iabp-electromechanical-system-used-to-inflate-and-deflat/) 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 I Reported 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 for CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3134-2024%22) Aug 8, 2024 FDA device enforcement ### [CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.](https://isitonrecall.com/recall/fda-device-z-3135-2024-cardiosave-rescue-intra-aortic-balloon-pump-iabp-electromechanical-system-used-to-inflate-and-deflat/) 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 I Reported 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 for CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3135-2024%22) Aug 8, 2024 FDA device enforcement ### [CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.](https://isitonrecall.com/recall/fda-device-z-3136-2024-cardiosave-hybrid-intra-aortic-balloon-pump-iabp-electromechanical-system-used-to-inflate-and-deflat/) 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 I Reported 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 for CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3136-2024%22) Aug 8, 2024 FDA device enforcement ### [CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.](https://isitonrecall.com/recall/fda-device-z-3137-2024-cardiosave-rescue-intra-aortic-balloon-pump-iabp-electromechanical-system-used-to-inflate-and-deflat/) 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 I Reported 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 for CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3137-2024%22) Jul 31, 2023 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...](https://isitonrecall.com/recall/fda-device-z-2431-2023-cardiosave-hybrid-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-31-0998-uc-0800-31-0998/) 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 I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2431-2023%22) Jul 31, 2023 FDA device enforcement ### [Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85](https://isitonrecall.com/recall/fda-device-z-2432-2023-cardiosave-rescue-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-75-0998-00-0800-83-0998/) 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 I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-8...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2432-2023%22) Jul 31, 2023 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...](https://isitonrecall.com/recall/fda-device-z-2433-2023-cardiosave-hybrid-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-31-0998-uc-0800-31-0998/) Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. Class I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2433-2023%22) Jul 31, 2023 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,](https://isitonrecall.com/recall/fda-device-z-2434-2023-cardiosave-rescue-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-75-0998-00-0800-83-0998/) Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. Class I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-8...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2434-2023%22) Jul 31, 2023 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...](https://isitonrecall.com/recall/fda-device-z-2435-2023-cardiosave-hybrid-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-31-0998-uc-0800-31-0998/) 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 I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2435-2023%22) Jul 31, 2023 FDA device enforcement ### [Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85](https://isitonrecall.com/recall/fda-device-z-2436-2023-cardiosave-rescue-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-75-0998-00-0800-83-0998/) 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 I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-8...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2436-2023%22) Jul 31, 2023 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...](https://isitonrecall.com/recall/fda-device-z-2437-2023-cardiosave-hybrid-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-31-0998-uc-0800-31-0998/) Users were identifying autofill failure conditions on the devices causing pump stops. Class I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2437-2023%22) Jul 31, 2023 FDA device enforcement ### [Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85](https://isitonrecall.com/recall/fda-device-z-2438-2023-cardiosave-rescue-intra-aortic-balloon-pumps-iabp-part-numbers-0998-00-0800-75-0998-00-0800-83-0998/) Users were identifying autofill failure conditions on the devices causing pump stops. Class I Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-8...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2438-2023%22) ## 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](https://isitonrecall.com/guides/read-lot-codes/) 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](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/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. ## Keep checking [Search Datascope Corp.](https://isitonrecall.com/check/?q=Datascope%20Corp.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)