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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax Medical C2 CryoBalloon Pear Focal Catheter

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  Class 2 Device Recall Pentax Medical C2 CryoBalloon Pear Focal Catheter see related information
Date Initiated by Firm December 03, 2018
Create Date May 14, 2019
Recall Status1 Terminated 3 on August 14, 2020
Recall Number Z-1326-2019
Recall Event ID 82274
510(K)Number K163684  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX.

Product Usage:
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
Code Information Lot/Serial numbers: 06152018-01, 07172018-02, 07022018-04, 08212018-01, and 08102018-03.
Recalling Firm/
Manufacturer		 PENTAX of America Inc
303 Convention Way
Ste 1
Redwood City CA 94063-1465
For Additional Information Contact Mr. Andy Wong
866-515-1861
Manufacturer Reason
for Recall		 Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
FDA Determined
Cause 2		 Under Investigation by firm
Action Letters dated 12/3/2018 were issued via USPS mailing on 12/3/2018 explaining the issue and instructing the customer to discontinue use of the device and to ensure all potential users in the customer facility are aware of the recall notification and recommended actions. For questions regarding this action, please contact PENTAX Medical Customer Service. Tel: 650-318-5899 (8:30 AM  5:00 PM, Monday  Friday, PST) Fax: 650-318-5899 Email: RMA@C2Therapeutics.com
Quantity in Commerce 68 devices
Distribution Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GEH and Original Applicant = C2 Therapeutics, Inc.
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