The Recall Desk
HighFDA (Devices)·Z-0182-2014·Announced 2013-11-20

Urologix Recalls Prostiva RF Therapy Hand Piece Kits Due to Deployment Force Issue

Urologix is recalling 142 Prostiva RF Therapy Hand Piece Kits because the hand piece deployment force exceeded maximum specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (exceeded deployment force specification) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Urologix, Inc. is recalling 142 units of the Prostiva RF Therapy Hand Piece Kit, REF 8929. This medical device is a prescription-only, single-use component used in the treatment of benign prostatic hyperplasia (BPH). The specific units involved are identified by Kit Lot Number 215251 and Hand Piece Lot Number 13E005M.

The recall was initiated because the hand piece high deployment force exceeded the maximum specification. The device is distributed nationwide, including in Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Tennessee, Texas, and Utah.

Healthcare providers and patients should stop using the affected hand piece kits and contact Urologix, Inc. for further instructions regarding the recall.

The recalled product

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
Manufacturer
Urologix, Inc.
Category
Medical Device — Urology
Hazard
Affected units
142

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Related recalls

Same hazard · mechanical defect

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