CLASS II Device recall · Reported 22 May 2019 · FDA Enforcement Report

Pentax Medical C2 CryoBalloon Standard Focal Catheter recalled

Pentax of America is recalling Pentax Medical C2 CryoBalloon Standard Focal Catheter, distributed in 17 states. The recall was initiated on 3 Dec 2018 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled157 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1325-2019
FDA event ID: 82274
Recalling firm: Pentax of America, Redwood City, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Dec 2018
FDA classified: 14 May 2019
Reported: 22 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

3 Dec 2018	Recall initiated by company
14 May 2019	Classified by FDA	+162 days
22 May 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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.

California District of Columbia Florida Louisiana Massachusetts Maryland Minnesota North Carolina New Jersey New York Ohio Pennsylvania South Carolina Tennessee Texas Virginia Washington

Questions about this recall

Why was it 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 lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82274

Reported	Class	Recall	Company	Reason	Where
22 May 2019	CLASS II	Pentax Medical C2 CryoBalloon Pear Focal Catheter recalled	Pentax of America	Foreign Material	17 states
22 May 2019	CLASS II	Pentax Medical C2 CryoBalloon Standard 90 degree Catheter recalled	Pentax of America	Foreign Material	17 states

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