Medtronic recall: Labeling Error
Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application…
Why was Medtronic recalled?
Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval
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?
The first released affected product was released to the market in April, 2005.
- Product
- Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 170,286 US, 73,921 OUS for all devices.
- Distribution
- Nationwide Distribution - all states including DC and Puerto Rico.
- Recall date
- May 7, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)