Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

The Better-Bladder With 14" ID tubing Recalled by Circulatory Technology Inc Due to Twisted or wrinkled balloon components which are considered...

Date: July 1, 2016
Company: Circulatory Technology Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Circulatory Technology Inc directly.

Affected Products

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.

Quantity: 958 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Circulatory Technology Inc

Circulatory Technology Inc has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report