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.

26–50 of 67

  • CriticalFDA (Devices)·Z-2218-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion

    Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.

    Product
    TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2220-2023·2023-08-02

    MEGA Intra-Aortic Balloon Catheter Introducer Fracture Poses Arterial Injury Risk

    Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.

    Product
    MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D68
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2217-2023·2023-08-02

    Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk

    The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.

    Product
    SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2219-2023·2023-08-02

    Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk

    Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.

    Product
    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2221-2023·2023-08-02

    Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk

    Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

    Product
    SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2216-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion

    The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.

    Product
    YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2150-2023·2023-07-26

    Intra-Aortic Balloon Pump may fail to charge batteries, interrupting therapy

    The Cardiosave Rescue Intra-Aortic Balloon Pump may lose battery charging ability in one or both bays, potentially interrupting therapy if disconnected from power. Low battery alarms may alert users before therapy stops.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2151-2023·2023-07-26

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalls due to unexpected device shutdown

    Datascope has recalled Cardiosave Hybrid IABP models due to tantalum capacitor failures that may cause unexpected device shutdown, interrupting life-critical cardiac therapy.

    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 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2149-2023·2023-07-26

    Cardiosave Hybrid IABP may fail to charge batteries, interrupting therapy

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may lose the ability to charge batteries in one or both bay slots, potentially interrupting critical therapy if disconnected from AC power. Low battery alarms may alert users before therapy is interrupted.

    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 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2152-2023·2023-07-26

    Cardiosave Rescue IABP Recalled Due to Unexpected Shutdown Risk

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to capacitor failures that may cause unexpected device shutdown. The devices may stop delivering therapy without warning.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2023·2023-06-21

    Cardiosave Hybrid IABP Recall: Incorrect Compliance Annotation in Instructions

    The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1462-2023·2023-05-03

    Cardiosave Hybrid Intra-Aortic Balloon Pump Power Cord Incompatible with Brazilian Outlet

    Datascope Corp. is recalling 54 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump distributed to Brazil. The Type J power cord plug is incompatible with Brazilian Type N electrical receptacles.

    Product
    MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1276-2023·2023-03-29

    Cardiosave Hybrid intra-aortic balloon pump safety disk defect may reduce therapy efficacy

    Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1278-2023·2023-03-29

    Cardiosave IABP Safety Disk Model 0202-00-0140 Recalled for Performance Defect

    Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1277-2023·2023-03-29

    Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall

    Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1279-2023·2023-03-29

    Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue

    Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1148-2023·2023-03-15

    Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly

    The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.

    Product
    Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1147-2023·2023-03-15

    Cardiosave Hybrid IABP Recalled for Risk of Unexpected Shutdown

    The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.

    Product
    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-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1145-2023·2023-03-15

    Cardiosave Hybrid IABP Devices Recalled for Unexpected Shutdown Risk

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.

    Product
    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, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1146-2023·2023-03-15

    Cardiosave Rescue Intra-Aortic Balloon Pumps recalled for connection failure

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2023·2023-03-15

    Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy

    Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.

    Product
    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, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2023·2023-03-15

    Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks

    Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.

    Product
    Cardiosave Rescue. Model Number: 0998-00-0800-83.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2023·2023-03-15

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

    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, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0886-2023·2023-01-25

    Cardiosave IABP may shut down unexpectedly due to blood contamination

    The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model 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.
    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.