Circulatory Technology Inc: Medical Device Recall in 2016 - (Recall #: Z-2832-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 1, 2016

Date Posted: September 21, 2016

Recall Number: Z-2832-2016

Event ID: 74991

Reason for Recall:

The seal between the balloon and the housing may leak.

Status: Terminated

Product Quantity: 20 units

Code Information:

Lot # 014648 USE BY: 09/01/2018

Distribution Pattern:

US Distribution to states of: LA, MI, NY, OH, OR & TX.

Voluntary or Mandated:

Voluntary: Firm initiated