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.

51–67 of 67

  • SevereFDA (Devices)·Z-1719-2018·2018-05-16

    Datascope recalls custom tubing kits with potential Better Bladder seal defect

    Datascope is recalling nine custom tubing kits because a seal defect in the Better Bladder device may allow air entry, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1725-2018·2018-05-16

    Datascope recalls NICU ECC Pack custom tubing kits due to seal defect

    Datascope is recalling specific NICU ECC Pack custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.

    Product
    NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1706-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling specific custom tubing kits because the Better Bladder device may allow air to enter, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1718-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 10 custom tubing kits because a seal defect may allow air to enter the housing, causing the balloon to collapse and reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1707-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling the Better Bladder device in some custom tubing kits because seal separation may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1720-2018·2018-05-16

    Datascope Recalls Custom Neonatal ECC Tubing Kits Due to Seal Defect

    Datascope is recalling seven custom neonatal ECMO tubing kits because a seal defect may allow air entry, potentially causing a drop in blood flow.

    Product
    BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1723-2018·2018-05-16

    Datascope Recalls Better Bladder Custom Tubing Kits Due to Seal Separation

    Datascope Corporation is recalling 10 units of the BEQ-T 25501 Better Bladder Pack, Custom Tubing Kit. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1732-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Seal Separation Risk

    Datascope Corporation is recalling four custom tubing kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1727-2018·2018-05-16

    Datascope recalls custom tubing kits due to seal separation risk

    Datascope is recalling four custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.

    Product
    ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1383-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 2,714 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use are missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart mu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 655 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions For Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2017·2017-05-31

    Datascope Recalls Intra-Aortic Balloon Catheters Due to Tip Seal Leak Failures

    Datascope is voluntarily removing 996 units of SENSATION PLUS Intra-Aortic Balloon Catheters due to internal pressure testing failures related to tip seal leaks.

    Product
    SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1769-2017·2017-04-19

    Datascope Recalls Custom Tubing Packs Due to Assembly Error

    Datascope Corporation is recalling 21 custom tubing packs with Bioline coating due to a reported assembly error on the oxygenator line.

    Product
    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterili
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2002-2016·2016-06-22

    Datascope Small Patient ECC Pack Recalled for Excess Endotoxin

    Datascope Corporation is recalling 17 units of Small Patient ECC Packs due to endotoxin levels exceeding regulatory limits. The affected units were distributed in Georgia.

    Product
    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1935-2016·2016-06-15

    Datascope Recalls Intra-Aortic Balloon Catheters Due to Incorrect Instruction Manual

    Datascope is recalling Mega and Sensation Plus Intra-Aortic Balloon Catheter kits because they were packaged with the wrong instruction manual for the STATLOCK device.

    Product
    MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Ballo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2568-2014·2014-09-10

    Datascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error

    Datascope Corporation is recalling Linear 7.5 FR 40cc Intra-Aortic Balloon Catheters due to a duplicate serial number label detected during label reconciliation.

    Product
    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
    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.