Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
C2 CryoBalloon Focal Catheter Recalled by PENTAX of America Inc Due to The catheter alignment arrow printed onto the strain...
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 Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Quantity: 57 units
Why Was This Recalled?
The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
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