Z-1926-2016Class II

Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable...

Name: Z-1926-2016 Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable...
Creator: Medtronic Neuromodulation
Published: 2016-05-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2016-05-03 / Terminated

FDA source

Medtronic Neuromodulation began a recall of Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of... on 2016-05-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1926-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-03
Posted: 2016-06-07
Terminated: 2017-08-04
Recalling firm: Medtronic Neuromodulation
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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
FDA root cause: Under Investigation by firm
Action: Consignees were sent on 5/3/2016 a Medtronic "Urgent Medical Device Safety notification" letter dated May 2016. The letter was addressed to "Healthcare Professional". The letter described the problem and the product involved in the recall. The letter listed the recommendation to patients to follow current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger. Consignees were also requested to complete and return the "Physician Reply Form:. For questions contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7 am - 6 pm CST.
Quantity in commerce: 60,941
Distribution: Worldwide Distribution
Product codes and lots: All lot/serial numbers are affected for both Model numbers 37714 and 97714.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1926-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1926-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)