FDA Device recall Z-1031-2013
Medtronic Prostiva RF Therapy Generator
- FDA Device
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of Medtronic Prostiva RF Therapy Generator by Medtronic Neuromodulation, citing 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 elec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1031-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | all Model 8930 radio frequency (RF) generators are affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1031-2013%22
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