PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 10, 2013 Initiated: February 27, 2013 #Z-1031-2013

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

Details

Recalling Firm
Medtronic Neuromodulation
Units Affected
848 (696 US, 152 OUS)
Distribution
Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Medtronic Neuromodulation. Units affected: 848 (696 US, 152 OUS).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2013. Severity: Moderate. Recall number: Z-1031-2013.

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