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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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