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Recall Observatory FDA recall evidence

Device product

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

Z-1862-2021

April 27, 2021

Class II

Product summary

Firm
Circulatory Technology Inc.
Event
Event 88000
Status
Ongoing
Classification
Class II
Quantity
147 units
Official record key
device-enforcement:Z-1862-2021

Official wording

Reason: 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.

Code information: Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021

Distribution pattern: US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.