Pentax recalls specific model cryo-balloon catheters due to potential incorrect dose transmission if RFID tag is unreadable by controller. 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 cryo-balloon catheters that may transmit incorrect dose settings to the controller if the RFID tag isn't properly read. This could lead to improper treatment during medical procedures.
The catheter's RFID tag must be correctly read by the controller to send accurate dose settings. If the tag isn't properly read, the system may transmit incorrect dose increments, potentially causing improper treatment.
Medical professionals using the Pentax C2 CryoBalloon system for endoscopic procedures are most at risk. Patients receiving this treatment may be affected if the catheter is used incorrectly.
Check for the model number FG 1024 on the catheter. Affected units have specific lot numbers: 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.
Ensure the catheter's RFID tag is readable by the controller before use.
The recalled model is Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024.
Affected lot numbers are 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.
Check for the model number FG 1024 and the specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-1326-2019 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-1326-2019 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.
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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.
