Z-1031-2013Class II

Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms...

Name: Z-1031-2013 Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms...
Creator: Medtronic Neuromodulation
Published: 2013-02-27
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2013-02-27 / Terminated / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to... on 2013-02-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1031-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-27
Posted: 2013-04-02
Terminated: 2013-11-21
Recalling firm: Medtronic Neuromodulation
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic sent a "Urgent Medical Device Correction" letter dated January 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Medtronic has found through device testing that if the optional footswitch (Model 60883) 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 equipment. The status messages on the display screen and associated audible alarms operate as intended, and would notify the clinician of any change in status as described in chapter 2 of the system manual. Enclosed you will find an insulating cap that should be placed over the footswitch connector port when the Model 8930 RF Generator is used without the footswitch. The footswitch connector port is located on the rear panel of the Model 8930 RF Generator as shown below. For further questions In the United States, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 or your local product representative. Outside of the United States, contact your local product representative.
Quantity in commerce: 848 (696 US, 152 OUS)
Distribution: Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
Product codes and lots: all Model 8930 radio frequency (RF) generators are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1031-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1031-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-02

Product code GEI

K113380Class IIProstiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. / cleared 2012-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)