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.

26–50 of 67

  • HighFDA (Devices)·Z-2179-2018·2018-06-20

    Datascope Recalls Pediatric Cardiopulmonary Bypass Tubing Kits Due to Valve Defect

    Datascope Corporation is recalling 27 pediatric cardiopulmonary bypass tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The produc
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2180-2018·2018-06-20

    Datascope Recalls Maquet Cardiopulmonary Bypass Tubing Kits Due to Valve Defect

    Datascope Corporation is recalling eight Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product c
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2178-2018·2018-06-20

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 10 units of Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product cons
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2104-2018·2018-06-13

    Datascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure

    Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2106-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2105-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1709-2018·2018-05-16

    Datascope recalls BEQ-TOP 5210 ECC Set custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.

    Product
    BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1731-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling 11 custom tubing kits containing the Better Bladder device due to a seal defect that may cause balloon collapse and reduced blood flow.

    Product
    BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1714-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.

    Product
    BEQ-TOP 22701, Catalog No. 701050790
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1717-2018·2018-05-16

    Datascope Recalls Better Bladder Devices in Custom Tubing Kits

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

    Product
    BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1726-2018·2018-05-16

    Datascope Recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits

    Datascope is recalling four BEQ-TOP 24500 Adult ECC Custom Tubing Kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1722-2018·2018-05-16

    Datascope Better Bladder Custom Tubing Kit Recalled for Seal Separation

    Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.

    Product
    BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1721-2018·2018-05-16

    Datascope Custom Tubing Kit Recall Due to Seal Separation

    Datascope is recalling 9 custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1715-2018·2018-05-16

    Datascope recalls Better Bladder device due to seal separation risk

    Datascope is recalling the Better Bladder device because seal separation may cause balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1716-2018·2018-05-16

    Datascope Recalls Custom Tubing Packs Due to Potential Seal Separation

    Datascope is recalling 22 units of BEQ-TOP 33700 ECC 3/8" PACK custom tubing kits because a seal defect may cause balloon collapse and reduced blood flow.

    Product
    BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1730-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1733-2018·2018-05-16

    Datascope recalls custom pediatric ECMO tubing kits due to seal defect

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

    Product
    BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1724-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may allow air to enter the device, potentially causing a drop in ECMO blood flow.

    Product
    BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1729-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1710-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may allow air to enter the housing, potentially causing a drop in ECMO circuit blood flow.

    Product
    BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1728-2018·2018-05-16

    Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse

    Datascope Corporation is recalling BEQ-TOP 22301 Custom Tubing Kits because seal separation may allow air to enter the housing, causing the balloon to collapse and reducing blood flow.

    Product
    BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1713-2018·2018-05-16

    Datascope Recalls Better Bladder Device in Custom Tubing Kits

    Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may cause balloon collapse and reduced blood flow.

    Product
    BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1708-2018·2018-05-16

    Datascope Recalls Adult ECC Pack Due to Seal Separation Risk

    Datascope Corporation is recalling three units of the Adult ECC Pack BEQ-TOP 22300 because seal separation may allow air into the housing, potentially collapsing the balloon and reducing blood flow.

    Product
    Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1711-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope is recalling Better Bladder devices in custom tubing kits because seal separation may cause balloon collapse and reduced ECMO blood flow.

    Product
    BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1712-2018·2018-05-16

    Datascope Better Bladder Device Recalled Due to Seal Separation Risk

    Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.

    Product
    BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
    Category
    Medical Device
    Distribution
    13 states

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.