CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report

C2 CryoBalloon Focal Catheter recalled by PENTAX of America

Pentax of America is recalling C2 CryoBalloon Focal Catheter, distributed nationwide in the US. The recall was initiated on 30 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Codes: 02132018-01 & 02162018-03

Quantity recalled57 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2256-2018
FDA event ID: 80180
Recalling firm: Pentax of America, Redwood City, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2018
FDA classified: 19 Jun 2018
Reported: 27 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

30 Mar 2018	Recall initiated by company
19 Jun 2018	Classified by FDA	+81 days
27 Jun 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.

Where it was distributed

Distribution US nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Codes: 02132018-01 & 02162018-03

Where was it sold?

Distribution US nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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