Lower riskMedical device recall · FDA · Published December 3, 2018
Pentax Medical C2 CryoBalloon Catheter Recall: Incorrect Dose Transmission Risk
Pentax recalls specific models of cryosurgical catheters due to potential incorrect dose transmission to the controller, which could affect treatment safety. Affected units include certain lot numbers from 2018.
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.
Take action
Contact the company
📍Recalling firmPENTAX of America Inc303 Convention Way, Ste 1 · Redwood City, CA 94063-1465
“Pentax Medical C2 CryoBalloon Catheter Recall: Incorrect Dose Transmission Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69395-pentax-medical-c2-cryoballoon-catheter-recall-incorrect-dose-transmission-risk. Based on FDA recall #Z-1325-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1325-2019%22&limit=1).
Pentax of America Inc recalled the Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, because incorrect default doses may be transmitted to the controller if the RFID tag is unreadable. The Food and Drug Administration announced the voluntary Class II recall on Dec. 3, 2018.
How to tell if you have it
Brand: Pentax
Product: Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX
Lot codes: 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01
Quantity: 157 devices
The hazard
The 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.
Context
GovInfoNow's records show Pentax of America Inc has 10 other recalls on record since July 13, 2017. Other recent recalls include a Pentax EPK-i8020c Medical Video Processor recall on July 16, 2025, and a Pentax Medical Colonoscope recall on Jan. 29, 2025. Other recent recalls of similar products include Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray (Nov. 6, 2025), Penumbra RED 62 Reperfusion Catheter (July 24, 2026), and Penumbra RED 68 Reperfusion Catheter (June 3, 2026).
How to tell if you have this one
Check for the model number FG 1028 on the catheter, and lot/serial numbers starting with 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, or 9172018-01.
Brand
Pentax
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-1325-2019
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, 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.; Lot/Serial numbers: 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01.
157 devices
Z-1326-2019
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.; Lot/Serial numbers: 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.
68 devices
Z-1327-2019
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, 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.; Lot/Serial number 08062018-03
4 devices
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number (FG 1028) and lot/serial numbers listed in the recall notice to confirm if your catheter is affected.
Where it went and when
Where it was distributed
Distributed in 16 states and D.C., and outside the U.S.
Listed by the agency
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, District of Columbia, Florida, Louisiana, Maryland, Massachusetts, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1325-2019 (December 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1325-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.