Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
C2 CryoBalloon Controller Recalled by PENTAX of America Inc Due to The Controller does not detect overpressure in the...
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 PENTAX of America Inc directly.
Affected Products
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.
Quantity: 45
Why Was This Recalled?
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PENTAX of America Inc
PENTAX of America 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