Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pentax Medical C2 CryoBalloon Pear Focal Catheter Recalled by PENTAX of America Inc Due to Incorrect default dose and dose increments may be...
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
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: 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. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
Quantity: 68 devices
Why Was This Recalled?
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Where Was This Sold?
This product was distributed to 17 states: CA, FL, LA, MD, MA, MN, NJ, NY, NC, OH, PA, SC, TN, TX, VA, WA, DC
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