Pentax recalls C2 CryoBalloon Focal Catheter (REF FG-1009) due to potential detachment from controller during surgery. Affected units have specific lot codes.
The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
Pentax is recalling C2 CryoBalloon Focal Catheter (REF FG- 1009) because the alignment of the catheter arrow with the connector may cause it to detach from the controller during use. This could lead to the catheter partially ejection from the controller, posing a risk during cryosurgical procedures.
The catheter alignment arrow is not properly aligned with the detachment feature of the connector. This can cause the catheter to become partially detached (~1cm) from the controller during use, potentially leading to unintended disconnection during cryosurgical procedures.
Surgical teams using the C2 CryoBalloon Ablation System for endoscopic procedures are most at risk. Affected units have specific lot codes.
Check for lot codes 02132018-01 or 02162018-03 on the C2 CryoBalloon Focal Catheter (REF FG-1009). The product is used in endoscopic surgical applications.
Inspect the catheter alignment arrow to ensure it matches the connector's detachment feature. If misaligned, the catheter may detach during use.
The recalled catheter is C2 CryoBalloon Focal Catheter with reference number FG-1009.
Lot codes 02132018-01 and 02162018-03 are affected.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-2256-2018 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-2256-2018 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.
