FDA Device recall Z-2256-2018
C2 CryoBalloon Focal Catheter, REF FG-1009
- FDA Device
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of C2 CryoBalloon Focal Catheter, REF FG-1009 by Pentax, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2256-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-30 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pentax |
| Distribution | US |
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.
Identifiers
| code_info | Lot Codes: 02132018-01 & 02162018-03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2256-2018%22
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