Medtronic Neuromodulation: Medical Device Recall in 2014 - (Recall #: Z-1526-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 27, 2014

Date Posted: May 7, 2014

Recall Number: Z-1526-2014

Event ID: 66841

Reason for Recall:

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

Status: Terminated

Product Quantity: 170,286 US, 73,921 OUS for all devices.

Code Information:

The first released affected product was released to the market in April, 2005.

Distribution Pattern:

Nationwide Distribution - all states including DC and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated