Recall Z-2256-2018— PENTAX of America Inc
Class II · Terminated
Class II FDA medical device recall by PENTAX of America Inc, initiated 2018-03-30, terminated 2021-04-28. It names one FDA 510(k) clearance: K131523. Product: 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.. Reason: 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..
- Recalling firm
- PENTAX of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-30
- Terminated
- 2021-04-28
- Firm location
- Redwood City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.