Z-2256-2018Class II

C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in...

Name: Z-2256-2018 C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in...
Creator: PENTAX of America Inc
Published: 2018-03-30
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2018-03-30 / Terminated / root cause: supplier

FDA source

PENTAX of America Inc began a recall of 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... on 2018-03-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2256-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-30
Posted: 2018-06-05
Terminated: 2021-04-28
Recalling firm: PENTAX of America, Inc.
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.
Product code: GEH Unit, Cryosurgical, Accessories
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On 3/30/2018, C2 Therapeutics issued URGENT FIELD CORRECTION notices to customers via certified mail, return receipt requested. Customers are advised to take the following Action: - Forward a copy of the notice and the enclosures to the department in which is referenced in the notice. - Inspect stock and quarantine products identified within the notice. - The end user of the affected products should complete and return the response form via email to [email protected]. The response form contains an RMA number to allow for the return of devices affected by this field action, and enclosed in the package is a Federal Express shipping label for the returned merchandise. Customers with questions can call 650-318-5899, Monday through Friday 8:30 AM - 5 PM, PST.
Quantity in commerce: 57 units
Distribution: Distribution US nationwide.
Product codes and lots: Lot Codes: 02132018-01 & 02162018-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2256-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2256-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-19

Product code GEH

K131523Class IICryoballoon Focal Ablation SystemC2 Therapeutics / cleared 2013-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)