Pentax recalls specific models of cryosurgical catheters due to potential incorrect dose transmission to the controller, which could affect treatment safety. Affected units include certain lot numbers from 2018.
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.
Pentax is recalling specific models of cryosurgical catheters that may transmit incorrect dose settings to the controller, risking unsafe treatment. This could lead to improper ablation of tissue during procedures.
The catheter's RFID tag may not be correctly read by the controller, causing incorrect dose settings to be transmitted. This could result in improper tissue ablation during procedures, potentially leading to ineffective treatment or complications.
Healthcare professionals using the Pentax Medical C2 CryoBalloon Standard Focal Catheter (Model FG 1028) for endoscopic procedures are most at risk. Patients undergoing treatment with this device may be affected if the catheter is used incorrectly.
Check for the model number FG 1028 on the catheter, and lot/serial numbers starting with 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, or 9172018-01.
Identify the model number (FG 1028) and lot/serial numbers listed in the recall notice to confirm if your catheter is affected.
The recalled model is Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028.
Affected lot/serial numbers include 06152018-02, 06252018-03, 07062018-01, 07232018-02, 08102018-01, 08172018-06, 08292018-04, and 9172018-01.
The recall notice does not specify a remedy, so no action is required beyond checking if your catheter is affected.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-1325-2019 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-1325-2019 from Pentax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
