Medtronic Neuromodulation: Medical Device Recall in 2013 - (Recall #: Z-1031-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 27, 2013

Date Posted: April 10, 2013

Recall Number: Z-1031-2013

Event ID: 64497

Reason for Recall:

Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equi

Status: Terminated

Product Quantity: 848 (696 US, 152 OUS)

Code Information:

all Model 8930 radio frequency (RF) generators are affected

Distribution Pattern:

Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.

Voluntary or Mandated:

Voluntary: Firm initiated