The Recall Desk

Manufacturer

Datascope Corp.

67 recalls in our database name Datascope Corp. as the manufacturing or recalling firm.

What the numbers show

Total
67
Critical
11
Severe
26
Most recent
2026-03-25

Of the 67 recalls from Datascope Corp. we have scored against our rubric, 11 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (39%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–67 of 67

  • SevereFDA (Devices)·Z-0885-2023·2023-01-25

    Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.

    Product
    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, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2022·2021-12-22

    Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk

    Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.

    Product
    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-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2022·2021-12-22

    FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress

    Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.

    Product
    Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0091-2022·2021-10-27

    Cardiosave Li-Ion battery pack recalled for insufficient runtime specification

    Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.

    Product
    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, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2022·2021-10-13

    Cardiosave IABP helium indicator may show inaccurate readings during electromagnetic interference

    Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0075-2022·2021-10-13

    Cardiosave Hybrid IABP Display Helium Indicator May Misread in Electromagnetic Interference

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump devices because the helium indicator on the display may overestimate helium levels when electromagnetic interference is present.

    Product
    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, 0998-00-0800-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2021·2021-10-06

    Cardiosave Rescue IABP may unexpectedly shut down during operation

    Datascope Corp. is recalling the Cardiosave Rescue IABP (models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85) because the device may unexpectedly shut down when run on AC power with a single battery installed and that battery is removed during charging.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2615-2021·2021-10-06

    Cardiosave Hybrid IABP may unexpectedly shut down on AC power

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may unexpectedly shut down when running on AC power with one battery installed and the battery removed during charging. No injuries have been reported.

    Product
    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, 0998-00-0800-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2021·2021-05-05

    Datascope Cardiosave Hybrid IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    Product
    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, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1507-2021·2021-05-05

    Datascope Cardiosave Rescue IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Rescue IABP units due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    Product
    Cardiosave Rescue 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 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0266-2020·2019-11-13

    Datascope Recalls Low Level Output Cables for Intra-Aortic Balloon Pumps

    Datascope Corp. is recalling seven low level output cables for intra-aortic balloon pumps because they were packaged with incorrect cables.

    Product
    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
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1944-2019·2019-07-24

    Datascope CS300 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than the minimum required operating power.

    Product
    CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1939-2019·2019-07-24

    Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump Recalled for Labeling Defects

    Datascope Corp. is recalling 6,197 Cardiosave Hybrid Intra-Aortic Balloon Pumps worldwide due to inadequate labeling regarding battery maintenance.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1943-2019·2019-07-24

    Datascope CS300 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time.

    Product
    CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1942-2019·2019-07-24

    Datascope CS100 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than the minimum run time of operating power.

    Product
    CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2019·2019-07-24

    Datascope Cardiosave Rescue IABP Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling 6,197 Cardiosave Rescue IABP units because improper battery maintenance may result in less than minimum operating power.

    Product
    Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2019·2019-07-24

    Datascope CS100 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time. Revised labeling and training are being offered.

    Product
    CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Datascope

Founded
1964

Source: Wikidata (Q4037062), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.