Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Bigger-Better-Bladder Recalled by Circulatory Technology Inc Due to The seal between the balloon and the housing...
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 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.
Quantity: 20 units
Why Was This Recalled?
The seal between the balloon and the housing may leak.
Where Was This Sold?
This product was distributed to 6 states: LA, MI, NY, OH, OR, TX
About Circulatory Technology Inc
Circulatory Technology Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report