The Recall Desk
HighFDA (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.

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 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

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:

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