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U.S. Department of Health and Human Services

Class 2 Device Recall CRYOCARE SURGICAL SYSTEM

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  Class 2 Device Recall CRYOCARE SURGICAL SYSTEM see related information
Date Initiated by Firm December 05, 2008
Date Posted April 16, 2010
Recall Status1 Terminated 3 on October 21, 2010
Recall Number Z-1400-2010
Recall Event ID 54004
510(K)Number K011074  K060279  K023757  
Product Classification Cryosurgical unit and accessories. - Product Code GEH
Product V-Probe, Endocare Cryo V Probe model # Cryo 206V.

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 08-0522.
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 2		 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 and Original Applicant = ENDOCARE, INC.
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