Circulatory Technology Inc: Medical Device Recall in 2016 - (Recall #: Z-2050-2016)

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:

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

Product Classification:

Class II

Date Initiated: March 3, 2016

Date Posted: July 6, 2016

Recall Number: Z-2050-2016

Event ID: 73608

Reason for Recall:

The seal between the balloon and the housing may leak.

Status: Terminated

Product Quantity: 72 units

Code Information:

Lot # 014603 USE BY: 9/2018

Distribution Pattern:

US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA

Voluntary or Mandated:

Voluntary: Firm initiated