Device evidence

device-recall:cfres:126207

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.

Official recall number

Z-1526-2014

Evidence summary

Product code: LGW
Recall status: Terminated
Event initiated: February 27, 2014
Root cause: Labeling False and Misleading
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1526-2014