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Medtronic Neuromodulation recalls Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are asso
Recalled May 7, 2014 · FDA recall Z-1526-2014 · Medtronic Neuromodulation
Hazard
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 · FDA Class II
Units
170,286 US, 73,921 OUS for all devices.
Sold at
Nationwide Distribution - all states including DC and Puerto Rico.
Description
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
Product
Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →