Z-1926-2016 Class II Terminated
FDA device recall Z-1926-2016 was initiated by Medtronic Neuromodulation on May 3, 2016 and is designated Class II. 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… The recall status is terminated (terminated Aug 4, 2017). Affected quantity: 60,941.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2016
- Initiation Date
- May 3, 2016
- Termination Date
- Aug 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,941
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.
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.
Distribution Pattern
Worldwide Distribution
Code Information
All lot/serial numbers are affected for both Model numbers 37714 and 97714.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1926-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026