PlainRecalls
FDA Devices Moderate Class II Terminated

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 ablat

Reported: May 22, 2019 Initiated: December 3, 2018 #Z-1325-2019

Product Description

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.

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.

Details

Recalling Firm
PENTAX of America Inc
Units Affected
157 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.
Location
Redwood City, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by PENTAX of America Inc. Units affected: 157 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Moderate. Recall number: Z-1325-2019.

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