Class 2 Device Recall Prostiva RF Therapy Hand Piece Kit

• Date Initiated by Firm: October 21, 2013
• Date Posted: November 08, 2013
• Recall Status: Terminated on April 21, 2014
• Recall Number: Z-0182-2014
• Recall Event ID: 66598
• 510(K)Number: K113380
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide.; ; The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral; constriction and relieve BPH voiding symptoms.; The Prostiva RF Therapy System consists of the following major components:; " Radio Frequency Generator; " Hand Piece Kit; " Telescope; The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components:; " One sterile Hand Piece with radio; frequency cable (Model 8929); " One sterile Tubing System (Model 6101); " One non-sterile Return Electrode (Model 8934); ; The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent).
• Code Information: Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M.
• Recalling Firm/ Manufacturer: Urologix, Inc.; 14405 21st Ave N; Minneapolis MN 55447-4685
• For Additional Information Contact: Hope Przybilla; 763-404-8134
• Manufacturer Reason for Recall: A Hand Piece high deployment force exceeded the maximum specification.
• FDA Determined Cause: Process change control
• Action: Consignees were sent a Urologix Urgent Medical Device Recall letter dated October 21, 2013. The letter described the problem and the device involved in the recall. Advised consignees to examine their inventory and remove the recalled product. Requested consignees to complete and fax the "Customer Acknowledgement Form" to Hope Przybilla at 763-475-1443 or call her for questions. The consignees local representatives will be personally assisting them with the return process and ensuring that replacement product is offered and received promptly.
• Quantity in Commerce: 142
• Distribution: Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT.
• 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 = GEI and Original Applicant = MEDTRONIC INC.