FDA Device recall Z-1926-2016
Medtronic RestoreSensor, Model 37714
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Medtronic RestoreSensor, Model 37714 by Medtronic Neuromodulation, citing 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 de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1926-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-03 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
Product
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.
Reason
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.
Identifiers
| code_info | All lot/serial numbers are affected for both Model numbers 37714 and 97714. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2016%22
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