Z-0700-2017Class II

Model 37751 Recharger

Name: Z-0700-2017 Model 37751 Recharger
Creator: Medtronic Neuromodulation
Published: 2016-10-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2016-10-03 / Terminated / root cause: software

FDA source

Medtronic Neuromodulation began a recall of 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... on 2016-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0700-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-03
Posted: 2016-12-03
Terminated: 2022-05-04
Recalling firm: Medtronic Neuromodulation
Product: 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.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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.
Root cause tag: software
FDA root cause: Software change control
Action: Consignees were sent a series of documents which included an introductory Medtronic and "Urgent Medical Device Correction" letters dated September 2016. The urgent letters included one for Deep Brain Stimulation (DBS) and one for Spinal Cord Stimulation(SCS) . Each letter was addressed to Healthcare Professional. Only physicians associated with both SCS and DBS therapy received the cover letter. The letters provided information on "Background, Issues Mitigation, Recommendation, Additional Information and Patient Notification (DBS). Requested consignees to complete and return the Physician /HCP Reply Form. For questions contact Medtronic Technical Services at 1-800-707-0933 weekdays 7 am to 6pm, CT.
Quantity in commerce: 42,887
Distribution: Worldwide Distribution - US Nationwide including DC OUS: Canada and others.
Product codes and lots: serial numbers beginning with NKA4 or NKU4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0700-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0700-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-03

Product code MHY

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)