Data / Medical devices / United States / Datascope Corp.
Datascope Corp.: FDA-registered device maker in Mahwah, NJ, United States, 7 510(k) clearances
Datascope Corp. is registered with the FDA (registration 2249723) in Mahwah, NJ, United States. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated May 31, 2018. 38 recall events name it as the recalling firm (19 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2249723
- FEI number
- 3001418283
- Address
- 1300 Macarthur Blvd, Mahwah, NJ, United States, 07430
- Owner or operator
- Datascope Corp. (2221819)
- Roles
- Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- CARDIOSAVE Hybrid Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case, CARDIOSAVE Rescue Intra-Aortic Balloon Pump, CS100 Intra-Aortic Balloon Pump, CS100/CS100i, CS100i Intra-Aortic Balloon Pump, CS300, CS300 Intra-Aortic Balloon Pump and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Balloon, Intra-Aortic And Control | DSP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 31, 2018 | K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| October 12, 2017 | K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| January 31, 2017 | K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| July 2, 2015 | K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| September 15, 2011 | K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP | DSP | Substantially Equivalent | Cardiac Assist, Maquet Cardiovascular, LLC | accessdata.fda.gov |
| January 5, 2007 | K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| August 11, 2003 | K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 6, 2026 | 98432 | Class III | Ongoing | 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 insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station i | accessdata.fda.gov |
| January 23, 2026 | 98189 | Class II | Ongoing | 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. | accessdata.fda.gov |
| November 4, 2025 | 97946 | Class II | Ongoing | 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. | accessdata.fda.gov |
| October 23, 2025 | 97956 | Class III | Ongoing | Cardiosave Hybrid | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | accessdata.fda.gov |
| August 8, 2024 | 95168 | Class I | Ongoing | 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 Pump devices. | accessdata.fda.gov |
| August 8, 2024 | 95150 | Class I | Ongoing | 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 Pump devices. | accessdata.fda.gov |
| July 31, 2023 | 92501 | Class I | Ongoing | 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, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 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(ies) will not charge. | accessdata.fda.gov |
| July 31, 2023 | 92498 | Class I | Ongoing | 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, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0 | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. | accessdata.fda.gov |
| July 31, 2023 | 92491 | Class I | Ongoing | 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, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 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 IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasi | accessdata.fda.gov |
| July 31, 2023 | 92489 | Class II | Ongoing | 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, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0 | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. | accessdata.fda.gov |
| July 31, 2023 | 92480 | Class I | Ongoing | 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, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0 | Users were identifying autofill failure conditions on the devices causing pump stops. | accessdata.fda.gov |
| June 5, 2023 | 92335 | Class I | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-08 | An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy. | accessdata.fda.gov |
| June 5, 2023 | 92287 | Class I | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-08 | IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy. | accessdata.fda.gov |
| May 4, 2023 | 92214 | Class III | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX | The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. | accessdata.fda.gov |
| April 4, 2023 | 92021 | Class II | Ongoing | MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 | The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle. | accessdata.fda.gov |
| February 28, 2023 | 91652 | Class II | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-6 | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy. | accessdata.fda.gov |
| February 7, 2023 | 91645 | Class II | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0 | There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the intern | accessdata.fda.gov |
| February 7, 2023 | 91642 | Class II | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00 | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted. | accessdata.fda.gov |
| February 7, 2023 | 91603 | Class I | Ongoing | Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-3 | An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP. | accessdata.fda.gov |
| February 7, 2023 | 91602 | Class I | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800 | An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit. | accessdata.fda.gov |
| December 19, 2022 | 91179 | Class I | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0 | The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter. | accessdata.fda.gov |
| November 15, 2021 | 88983 | Class I | Ongoing | Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC- | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. | accessdata.fda.gov |
| September 21, 2021 | 88719 | Class I | Ongoing | Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800- | A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers. | accessdata.fda.gov |
| September 8, 2021 | 88664 | Class II | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998 | 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. | accessdata.fda.gov |
| September 8, 2021 | 88651 | Class II | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998 | The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. | accessdata.fda.gov |
| March 22, 2021 | 87482 | Class III | Ongoing | Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00 | 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). | accessdata.fda.gov |
| October 3, 2019 | 83927 | Class II | Terminated | Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03 | One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging. | accessdata.fda.gov |
| June 17, 2019 | 82897 | Class I | Ongoing | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use. | Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall. | accessdata.fda.gov |
| September 20, 2018 | 81055 | Class I | Ongoing | Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 | There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft. | accessdata.fda.gov |
| May 3, 2018 | 80003 | Class I | Ongoing | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179 | Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy. | accessdata.fda.gov |
| July 17, 2017 | 77877 | Class I | Ongoing | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diast | False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy. | accessdata.fda.gov |
| June 16, 2017 | 77566 | Class I | Terminated | CS 100i Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. | accessdata.fda.gov |
| December 23, 2016 | 76052 | Class II | Terminated | CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an e | Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped. | accessdata.fda.gov |
| December 16, 2015 | 72890 | Class II | Terminated | Cardiosave Hybrid and rescue IABP | Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. | accessdata.fda.gov |
| January 30, 2015 | 70510 | Class II | Terminated | Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) | Power supply malfunction complaints related to suboptimal thermal management. | accessdata.fda.gov |
| December 16, 2014 | 69863 | Class II | Terminated | CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC- | Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle. | accessdata.fda.gov |
| March 21, 2014 | 67815 | Class I | Terminated | Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular proced | Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. | accessdata.fda.gov |
| March 16, 2011 | 58661 | Not yet classified | Terminated | Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intr | Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down. | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.