The Medtronic recall: Labeling Error
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System…
Why was The Medtronic recalled?
Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.
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 lot/serial numbers are affected for all 4 Model numbers: " Model 7425 " Model 3058 " Model 3023 " Model 3116
- Product
- The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 396,975 (258,805 USA, 138,170 OUS)
- Distribution
- Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada
- Recall date
- March 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)