Medtronic Neuromodulation: Medical Device Recall in 2023 - (Recall #: Z-0354-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Product Classification:

Class II

Date Initiated: October 19, 2023

Date Posted: November 29, 2023

Recall Number: Z-0354-2024

Event ID: 93303

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.

Status: Ongoing

Product Quantity: 26 units

Code Information:

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

Distribution Pattern:

International distribution to the countries of S. Korea and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated