Class 2 Device Recall CRYOCARE SURGICAL SYSTEM

• Date Initiated by Firm: December 05, 2008
• Date Posted: April 16, 2010
• Recall Status: Terminated on October 21, 2010
• Recall Number: Z-1401-2010
• Recall Event ID: 54004
• 510(K)Number: K011074 K023757 K060279
• Product Classification: Cryosurgical unit and accessories. - Product Code GEH
• Product: 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.
• Code Information: Lot Numbers 08-0539.
• FEI Number: 3008262715
• Recalling Firm/ Manufacturer: Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.; 201 Technology Dr; Irvine CA 92618-2400
• For Additional Information Contact: 949-450-5400
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 22,741 units total for all products
• Distribution: Nationwide.
• 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