Agency classClass IIOur severity:High FDA (Devices)·Z-1031-2013·Announced 2013-04-10

Medtronic Recalls Prostiva RF Therapy Generators Due to Static Electricity Risk

Medtronic is recalling 848 Prostiva RF Therapy Generators because static electricity may unintentionally start or stop the treatment process if the footswitch is not connected.

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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Medtronic Neuromodulation is recalling 848 units of the Prostiva RF Therapy Generator, Model 8930. The device is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3. The recall covers units distributed nationwide, including Puerto Rico and all states in the continental USA except Idaho, Montana, and New Hampshire.

The recall was initiated after device testing revealed that if the optional footswitch is not connected to the generator during use, an electrostatic discharge (static electricity) to the footswitch connector port may toggle the radio frequency (RF) output on or off. This malfunction could result in unintentionally starting or stopping the lesion process, depending on the current status of the equipment.

The source text does not specify the required actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect. The agency classification for this recall is Class II.

The recalled product

Product: Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Surgical / Therapeutic
Hazard: electrostatic-discharge
unintended-operation

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 (1)

all Model 8930 radio frequency (RF) generators are affected

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Medtronic Neuromodulation

See all →

Moderate
Medtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
Moderate
Medtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
High
Medtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
Moderate
Neurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
High
Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31

Same hazard · electrostatic discharge