CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report

Model 97745 Controller used with Models 97715 and 97716 Intellis recalled

Medtronic Neuromodulation is recalling Model 97745 Controller used with Models 97715 and 97716 Intellis. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/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

Quantity recalled26 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0354-2024
FDA event ID: 93303
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 19 Oct 2023
FDA classified: 20 Nov 2023
Reported: 29 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Oct 2023	Recall initiated by company
20 Nov 2023	Classified by FDA	+32 days
29 Nov 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Where it was distributed

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

Questions about this recall

Why was it recalled?

Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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