Z-0354-2024Class II

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Name: Z-0354-2024 Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Creator: Medtronic Neuromodulation
Published: 2023-10-19
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2023-10-19 / Open, Classified / root cause: software

FDA source

Medtronic Neuromodulation began a recall of Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators on 2023-10-19. FDA classified it as Class II and gives the reason as "Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0354-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-19
Posted: 2023-11-20
Recalling firm: Medtronic Neuromodulation
Product: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees via regionally approved method beginning 10/19/2023. The notice explained the issue, potential risk to the patient, and requested the return of the units.
Quantity in commerce: 26 units
Distribution: International distribution to the countries of S. Korea and Turkey.
Product codes and lots: UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0354-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0354-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)