Z-1326-2019Class II

Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX

Name: Z-1326-2019 Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX
Creator: PENTAX of America Inc
Published: 2018-12-03
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2018-12-03 / Terminated

FDA source

PENTAX of America Inc began a recall of Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a... on 2018-12-03. FDA classified it as Class II and gives the reason as "Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1326-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-03
Posted: 2019-05-14
Terminated: 2020-08-14
Recalling firm: PENTAX of America, Inc.
Product: Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
FDA root cause: Under Investigation by firm
Action: Letters dated 12/3/2018 were issued via USPS mailing on 12/3/2018 explaining the issue and instructing the customer to discontinue use of the device and to ensure all potential users in the customer facility are aware of the recall notification and recommended actions. For questions regarding this action, please contact PENTAX Medical Customer Service. Tel: 650-318-5899 (8:30 AM 5:00 PM, Monday Friday, PST) Fax: 650-318-5899 Email: [email protected]
Quantity in commerce: 68 devices
Distribution: Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
Product codes and lots: Lot/Serial numbers: 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1326-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1325-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-14
Z-1326-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-14
Z-1327-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-14

Product code GEH

K163684Class IIC2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. / cleared 2018-01-23

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)