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
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.
Questions about this recall
Why was it recalled?
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.
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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