PENTAX of America Inc recalls C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field…

Recall date

March 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2256-2018

FDA classification

Class II

Brand / firm

PENTAX of America Inc

Sold / distributed

Distribution US 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.