Pentax Medical C2 CryoBalloon Standard 90 degree Catheter — Class II medical device recall Z-1327-2019
Terminated recall by PENTAX of America Inc, reported 2019-05-22, distributed in CA, DC, FL, LA, MA, MD, MN, NC…. Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is no
| Recall number | Z-1327-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PENTAX of America Inc, Redwood City, CA, United States |
| Recall initiated | 2018-12-03 |
| Classified | 2019-05-14 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-08-14 |
| Distributed | CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA |
| Countries outside the US | CA, DE, NL |
| Quantity | 4 devices |
| Serial numbers | 08062018-03 |
| Model numbers | 1030 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1327-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.