Z-0182-2014Class II

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

Name: Z-0182-2014 Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model...
Creator: Urologix, Inc.
Published: 2013-10-21
License: https://open.fda.gov/license/

Urologix, LLC / initiated 2013-10-21 / Terminated

FDA source

Urologix, Inc. began a recall of 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... on 2013-10-21. FDA classified it as Class II and gives the reason as "A Hand Piece high deployment force exceeded the maximum specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0182-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-21
Posted: 2013-11-08
Terminated: 2014-04-21
Recalling firm: Urologix, LLC
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).
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: A Hand Piece high deployment force exceeded the maximum specification.
FDA root 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.
Product codes and lots: Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0182-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0182-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

Product code GEI

K113380Class IIProstiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. / cleared 2012-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)