FDA Medical Device Recalls (openFDA)
PENTAX of America Inc: C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 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.
- Recall number
- Z-0970-2019
- Recalling firm
- PENTAX of America Inc
- Product
- C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 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.
- Status
- Terminated
- Initiated
- 2018-12-03
- Posted
- not on file
- Terminated
- 2020-08-21
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 10/18/18, the firm, Pentax Medical, started contacting US Affected Customers by telephone to inform them of the pending action and to advise they discontinue use and quarantine affected devices. On 12/03/18, "URGENT MEDICAL DEVICE REMOVAL" letters dated 11/16/18 were mailed via USPS Certified Mail to its customers. Customer response forms and Customer Return Material Shipment Labels were mailed with the removal notices. Customers were informed that affected products should not be used and should be returned to the firm. In addition, customers were asked to ensure that all potential users in their facilities are made aware of the removal notice and the recommended actions. Customers were asked to complete and return the Field Action Response Form via: Fax to PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or Email a pdf copy to customeradvisories@pentaxmedical.com, or mail with the returned affected product to:Pentax of America Inc,,303 Convention Way Suite 1, Redwood City, CA 94063, Attention: 2018-009-R Action. . Customers with additional questions were encouraged to call 650-318-5899 (8:30 AM - 5:00 PM, Monday - Friday, PST).
- Quantity
- 45
- 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.
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- K163684
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3008780134
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28