Medtronic Prostiva RF Therapy Generator. The Prostiva recall
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction…
Why was Medtronic Prostiva RF Therapy Generator. The Prostiva 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all Model 8930 radio frequency (RF) generators are affected
- Product
- Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 848 (696 US, 152 OUS)
- Distribution
- Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
- Recall date
- April 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)