PENTAX of America Inc: 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.

Agency Publication Date: May 14, 2019

Affected Products

Product: 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

Lot/Serial numbers: 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01.

Product: 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

Lot/Serial numbers: 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.

Product: 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 a

Lot/Serial number 08062018-03

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82274

Status: Resolved

Manufacturer: PENTAX of America Inc

Manufactured In: United States

Units Affected: 3 products (157 devices; 68 devices; 4 devices)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot/Serial numbers: 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01.

Lot/Serial numbers: 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.

Lot/Serial number 08062018-03