Pentax recalls C2 CryoBalloon Controller software v1.18.258 due to potential balloon overpressure during nitrous oxide use, risking tissue injury. Affected units sold with specific reference numbers.
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Pentax is recalling a specific software version for their C2 CryoBalloon Controller. This software version may not detect overpressure in the balloon during nitrous oxide treatment, which could lead to tissue damage if the catheter is kinked.
The controller software fails to detect overpressure in the balloon when using non-dosing puffs of nitrous oxide. If the catheter becomes kinked and blocks the vent lumen, pressure builds up inside the balloon. This can cause tissue damage like perforation or laceration in the patient.
Patients undergoing cryosurgery for dysplastic Barrett's esophagus using the C2 CryoBalloon Ablation System with the recalled software version are most at risk. Medical professionals using this device for endoscopic procedures may also be affected.
Check for the reference number FG-1017 and software version v1.18.258 on the C2 CryoBalloon Controller. The device is used in cryosurgery for treating dysplastic Barrett's esophagus.
Look for the software version number on the controller device.
Reach out to Pentax of America Inc for assistance with the recall.
The recalled software version is v1.18.258.
Using the recalled software may cause balloon overpressure, potentially leading to tissue damage like perforation or laceration.
Check for the reference number FG-1017 and software version v1.18.258 on the C2 CryoBalloon Controller.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-0970-2019 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-0970-2019 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.
