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Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Pr...

FDA Device Recall #Z-0182-2014 — Class II — October 21, 2013

Recall Summary

Recall Number Z-0182-2014
Classification Class II — Moderate risk
Date Initiated October 21, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Urologix, Inc.
Location Minneapolis, MN
Product Type Devices
Quantity 142

Product Description

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).

Reason for Recall

A Hand Piece high deployment force exceeded the maximum specification.

Distribution Pattern

Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT.

Lot / Code Information

Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M.

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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