FDAFDA · Food and drugs·Recall number Z-1031-2013
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.
Published April 10, 2013 · Recall initiated: February 27, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
- Lot
- all Model 8930 radio frequency (RF) generators are affected
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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