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Terminated

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.

FDA Recall Z-1327-2019 · Posted None

Recalling FirmPENTAX of America Inc
Recall StatusTerminated
Product CodeGEH
Date Initiated2018-12-03
Date Terminated2020-08-14
Product Quantity4 devices

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.

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]

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018-01-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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