C2 CryoBalloon Focal Catheter recall
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery…
Why was C2 CryoBalloon Focal Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Codes: 02132018-01 & 02162018-03
- Product
- C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery…
- Recalling firm
- PENTAX of America Inc
- Quantity
- 57 units
- Distribution
- Distribution US nationwide.
- Recall date
- June 27, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)