Circulatory Technology Recalls

The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

Class I - Dangerous

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.

Apr 27, 2021 Other Medical Devices Nationwide View Details →

**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)

Class I - Dangerous

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.

Sep 22, 2017 Infusion Pumps View Details →

Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)

Class I - Dangerous

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.

Sep 22, 2017 Infusion Pumps View Details →

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.

Class I - Dangerous

Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

Jul 1, 2016 Infusion Pumps Nationwide View Details →

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 can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

Class I - Dangerous

The seal between the balloon and the housing may leak.

Jul 1, 2016 Patient Monitors View Details →

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Class I - Dangerous

The seal between the balloon and the housing may leak.

Mar 3, 2016 Other Medical Devices View Details →