Medtronic Neuromodulation: Medical Device Recall in 2016 - (Recall #: Z-1926-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

Product Classification:

Class II

Date Initiated: May 3, 2016

Date Posted: June 15, 2016

Recall Number: Z-1926-2016

Event ID: 74059

Reason for Recall:

Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.

Status: Terminated

Product Quantity: 60,941

Code Information:

All lot/serial numbers are affected for both Model numbers 37714 and 97714.

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated