Reported Jun 27, 2018 · Terminated
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field…
Pentax of America Inc
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PENTAX of America Inc · 303 Convention Way Ste 1 · Redwood City, CA · 94063-1415
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Codes02132018-01 & 02162018-03
- Amount recalled
- 57 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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