Recall of Device Recall Catheter, C2 CryoBalloon Ablation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C2 Therapeutics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    80180
  • Event Risk Class
    Class 2
  • Event Number
    Z-2256-2018
  • Event Initiated Date
    2018-03-30
  • Event Date Posted
    2018-06-05
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, cryosurgical, accessories - Product Code GEH
  • Reason
    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.
  • Action
    On 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.

Device

  • Model / Serial
    Lot Codes: 02132018-01 & 02162018-03
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide.
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    C2 Therapeutics, Inc., 303 Convention Way Ste 1, Redwood City CA 94063-1415
  • Manufacturer Parent Company (2017)
  • Source
    USFDA