Pentax recalls C2 CryoBalloon Controller software v1.18.258 due to potential balloon overpressure during nitrous oxide use, risking tissue injury. Affected units sold with specific reference numbers.
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Take action
Contact the company
📍Recalling firmPENTAX of America Inc303 Convention Way, Ste 1 · Redwood City, CA 94063-1465
“Pentax C2 CryoBalloon Controller Software v1.18.258 Recall: Risk of Balloon Overpressure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69397-pentax-c2-cryoballoon-controller-software-v1-18-258-recall-risk. Based on FDA recall #Z-0970-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0970-2019%22&limit=1).
Pentax of America Inc recalled the C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258, according to the FDA on 2018-12-03. The device may fail to detect overpressure in the balloon during use, potentially causing adverse events such as perforation or mucosal laceration.
How to tell if you have it
Brand: Pentax
Product: C2 CryoBalloon Controller
REF: FG-1017
Controller Software v1.18.258
Units affected: 45
The hazard
The controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide if the catheter is kinked. If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Context
GovInfoNow's records show Pentax of America Inc has 10 other recalls on record since 2017-07-13. Other recent recalls include the Pentax EPK-i8020c Medical Video Processor Recall (2025-07-16) and the Pentax Medical Colonoscope Recall (2025-01-29). Similar recent recalls of other products include the Olympus UHI-2 Insufflation Unit Recall (2026-01-16), the ConMed AirSeal 5mm Access Port Recall (2026-05-14), and the ConMed AirSeal 8mm Access Port Recall (2026-05-14).
How to tell if you have this one
Check for the reference number FG-1017 and software version v1.18.258 on the C2 CryoBalloon Controller. The device is used in cryosurgery for treating dysplastic Barrett's esophagus.
Brand
Pentax
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version number on the controller device.
Contact Manufacturer
Reach out to Pentax of America Inc for assistance with the recall.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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 21 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-0970-2019 (December 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0970-2019 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.