Z-0700-2017 Class II Terminated
FDA device recall Z-0700-2017 was initiated by Medtronic Neuromodulation on Oct 3, 2016 and is designated Class II. Reason for recall: Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging… The recall status is terminated (terminated May 4, 2022). Affected quantity: 42,887.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2016
- Initiation Date
- Oct 3, 2016
- Termination Date
- May 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,887
Product Description
Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model 37761) and an antenna.
Reason for Recall
Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems,Spinal Cord Stimulation)that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. Medtronic has determined all Rechargers manufactured starting in November 2014 (indicated by serial numbers beginning with NKA4 or NKU4 ) are more susceptible to this error state.
Distribution Pattern
Worldwide Distribution - US Nationwide including DC OUS: Canada and others.
Code Information
serial numbers beginning with NKA4 or NKU4
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0700-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026