Circulatory Technology Inc.: Medical Device Recall in 2021 - (Recall #: Z-1862-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 27, 2021

Date Posted: June 23, 2021

Recall Number: Z-1862-2021

Event ID: 88000

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 147 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated