C2 CryoBalloon Focal Catheter — Class II medical device recall Z-2256-2018
Terminated recall by PENTAX of America Inc, reported 2018-06-27, distributed nationwide. The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the
| Recall number | Z-2256-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PENTAX of America Inc, Redwood City, CA, United States |
| Recall initiated | 2018-03-30 |
| Classified | 2018-06-19 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 57 units |
| Reason classes | device malfunction |
| Lot numbers | 02132018-01, 02162018-03 |
| Model numbers | FG-1009 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2256-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.