Events

Recall of Device Recall CRYOCARE SURGICAL SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endocare, a Wholly Owned Subsidiary of HealthTronics, 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
    54004
  • Event Risk Class
    Class 2
  • Event Number
    Z-1401-2010
  • Event Initiated Date
    2008-12-05
  • Event Date Posted
    2010-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87243
  • 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
    Cryosurgical unit and accessories. - Product Code GEH
  • Reason
    Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. an autopsy attributed the cause of death to an air embolism. the safety notice for the cryoprobes was issued to refocus attention on the indications and safety review included with the physician training materials and to reinforce additional safety information.
  • Action
    The recall was initiated with Endocare sending a notification letter to identified customers on December 5, 2008 and offering an optional replacement unit. The initial correspondence was sent out via an e-mail if the correspondence was returned undeliverable or an e-mail address was not available it was then sent Federal Express to those recipients. The notification letter explained the reason for recall and requested providers refocus their attention on the Indications & Safety Review information contained in the Endocare's Physician Training Materials. Physicians were instructed to contact the firm at 1-949-450-5412 to discuss any questions they may have about the information in the notification letter.

Device

Device Recall CRYOCARE SURGICAL SYSTEM
  • Model / Serial
    Lot Numbers 08-0539.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. || The product is used in a minimally invasive, percutaneous approach || to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.
  • Manufacturer
    Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.

Manufacturer

Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
  • Manufacturer Address
    Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc., 201 Technology Dr, Irvine CA 92618-2400
  • Source
    USFDA