Events

Recall of Device Recall CSA Medical truFreeze Console

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

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
    70851
  • Event Risk Class
    Class 2
  • Event Number
    Z-1513-2015
  • Event Initiated Date
    2015-03-25
  • Event Date Posted
    2015-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135174
  • 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
    Trufreeze console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax.
  • Action
    CSA Medical issued letter dated 3/25/15 advising users of the problem. Users provided with: The mitigations available to the active venting procedures coupled with the extremely unlikely probability of injury, rare risk, thus allowing the physician to continue with active venting procedures. In regards a passive venting procedure may not have sufficient mitigation to allow the physician to identify the potential hazard with sufficient time to preclude a potential for injury. Therefore, passive users will be instructed not to use the system until a software improvement is put into place. Additionally, no catheters or consoles will be shipped to passive venting users of truFreeze. A response form to be signed and returned confirming receipt of the notification.Questions contact: Stephen Mascioli, MD 781-538-4755 smascioli@csamedical.com.

Device

Device Recall CSA Medical truFreeze Console
  • Model / Serial
    Serial Numbers:  01-00106 through 01-00201
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device || Model: CC3-01
  • Manufacturer
    CSA Medical

Manufacturer

CSA Medical
  • Manufacturer Address
    CSA Medical, 91 Hartwell Ave, Lexington MA 02421-3137
  • Manufacturer Parent Company (2017)
    CSA Medical Inc.
  • Source
    USFDA