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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter, C2 CryoBalloon Ablation System

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 Class 2 Device Recall Catheter, C2 CryoBalloon Ablation Systemsee related information
Date Initiated by FirmMarch 30, 2018
Date PostedJune 05, 2018
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-2256-2018
Recall Event ID 80180
510(K)NumberK131523 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductC2 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.
Code Information Lot Codes: 02132018-01 & 02162018-03
FEI Number 3008780134
Recalling Firm/
Manufacturer		 PENTAX of America Inc
303 Convention Way Ste 1
Redwood City CA 94063-1415
For Additional Information ContactAndy Wong
650-521-5304
Manufacturer 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.
FDA Determined
Cause 2		Vendor change control
ActionOn 3/30/2018, C2 Therapeutics issued URGENT FIELD CORRECTION notices to customers via certified mail, return receipt requested. Customers are advised to take the following Action: - Forward a copy of the notice and the enclosures to the department in which is referenced in the notice. - Inspect stock and quarantine products identified within the notice. - The end user of the affected products should complete and return the response form via email to RMA@c2therapeutics.com. The response form contains an RMA number to allow for the return of devices affected by this field action, and enclosed in the package is a Federal Express shipping label for the returned merchandise. Customers with questions can call 650-318-5899, Monday through Friday 8:30 AM - 5 PM, PST.
Quantity in Commerce57 units
DistributionDistribution US nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEH
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