The Recall Desk

Manufacturer

Datascope Corporation

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

What the numbers show

Total
67
Critical
0
Severe
27
Most recent
2022-11-02

Of the 67 recalls from Datascope Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (40%) 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.

1–25 of 67

  • HighFDA (Devices)·Z-0131-2023·2022-11-02

    LINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling

    Datascope's LINEAR intra-aortic balloon catheter has an incorrect balloon volume label on internal instructions that may delay critical therapy in unstable patients.

    Product
    LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1686-2022·2022-09-14

    FDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect

    Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.

    Product
    Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1685-2022·2022-09-14

    MEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator

    Datascope Corporation is recalling 10,427 units of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator in certain lots. The device has been distributed internationally and is awaiting domestic distribution.

    Product
    MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1687-2022·2022-09-14

    Undersized Dilator in Balloon Catheter Insertion Kit Recalled

    Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.

    Product
    Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2831-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,275 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2837-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2843-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2839-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 54,816 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2838-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,746 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2836-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 29,653 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2835-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling 32,855 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2833-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2847-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling 3,055 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2841-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling 2,550 kits of Trans-Ray 7Fr 34cc Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected devices were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2842-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling specific Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2845-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling 6,111 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects units distributed worldwide.

    Product
    Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2834-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2844-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers 11,555 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2846-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling 3,542 Intra-Aortic Balloon Catheter kits worldwide due to potential endotoxin contamination.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2840-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0934-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0932-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets due to potential sterility compromise in breached pouches.

    Product
    Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1966-2019·2019-07-24

    Datascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels

    Datascope is recalling 471 Sensation Plus Intra-Aortic Balloon Catheters because the outer cartons displayed the manufacture and expiry dates in reverse.

    Product
    Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stab
    Category
    Medical Device
    Distribution
    1 state

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.