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.
Reported: June 27, 2018 Initiated: March 30, 2018 #Z-2256-2018
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.
Details
- Recalling Firm
- PENTAX of America Inc
- Units Affected
- 57 units
- Distribution
- Distribution US nationwide.
- Location
- Redwood City, CA
Frequently Asked Questions
What product 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.. Recalled by PENTAX of America Inc. Units affected: 57 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2018. Severity: Moderate. Recall number: Z-2256-2018.
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