Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93303

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 19, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Neuromodulation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Z-0354-2024
Recall number
Z-0354-2024
Initiated
October 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neuromodulation
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

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.