Z-1031-2013 Class II Terminated
FDA device recall Z-1031-2013 was initiated by Medtronic Neuromodulation on Feb 27, 2013 and is designated Class II. 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… The recall status is terminated (terminated Nov 21, 2013). Affected quantity: 848 (696 US, 152 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2013
- Initiation Date
- Feb 27, 2013
- Termination Date
- Nov 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 848 (696 US, 152 OUS)
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.
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
Distribution Pattern
Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
Code Information
all Model 8930 radio frequency (RF) generators are affected
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1031-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026