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Circulatory Technology Recalls
6 recalls on record · July 6, 2016 to June 23, 2021 · Medical Devices
Recalls by year
16
18
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 23, 2021Medical DevicesFDA
Circulatory Technology Inc. recalls The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB
Hazard: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
March 7, 2018Medical DevicesFDA
Circulatory Technology Inc recalls **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (indi
Hazard: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
March 7, 2018Medical DevicesFDA
Circulatory Technology Inc recalls Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk
Hazard: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
October 19, 2016Medical DevicesFDA
Circulatory Technology Inc recalls The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circu
Hazard: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
September 21, 2016Medical DevicesFDA
Circulatory Technology Inc recalls The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tr
Hazard: The seal between the balloon and the housing may leak.
July 6, 2016Medical DevicesFDA
Circulatory Technology Inc recalls Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Hazard: The seal between the balloon and the housing may leak.