The Recall Desk

Manufacturer

Circulatory Technology Inc.

6 recalls in our database name Circulatory Technology Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
2
Most recent
2021-06-23

Of the 6 recalls from Circulatory Technology Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (33%) 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.

1–6 of 6

  • HighFDA (Devices)·Z-1862-2021·2021-06-23

    Better-Bladder ECMO Device May Collapse, Reducing Blood Flow

    The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.

    Product
    The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1171-2018·2018-03-07

    Circulatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs

    Circulatory Technology Inc is recalling specific models of cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.

    Product
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0817-2018·2018-03-07

    Circulatory Technology Recalls Better-Bladder ECMO Blood Reservoirs

    Circulatory Technology Inc is recalling Better-Bladder cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.

    Product
    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-0057-2017·2016-10-19

    Circulatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects

    Circulatory Technology Inc is recalling 958 units of Better-Bladder devices with 14-inch tubing due to twisted or wrinkled balloon components.

    Product
    The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2016·2016-09-21

    Circulatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak

    Circulatory Technology Inc is recalling 20 units of the Bigger-Better-Bladder, TM 2 device because the seal between the balloon and housing may leak.

    Product
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal c
    Category
    Medical Device
    Distribution
    6 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.

Circulatory Technology (United States)

company in Oyster Bay, United States

Country
United States

Source: Wikidata (Q30283007), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.