fda_recall · device_recall · high
Medtronic Neuromodulation — Class II recall: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulator…
- Event date
- 2023-11-29 00:00:00Z
- Observed
- 2026-07-16 23:20:08Z
- Source ID
- Z-0354-2024
- Payload hash
- cdc1a7236db85fec2a4496e5…
Summary
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.
Entities
Frequently asked questions
- Has Medtronic Neuromodulation had other FDA enforcement actions?
- Yes. Argus HQ has recorded 36 total FDA actions tied to Medtronic Neuromodulation: 0 warning letters, 36 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What kind of FDA record is this?
- This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-11-29; Argus observed and indexed it on 2026-07-16.
- Where can I verify this record directly with FDA?
- The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
APA
Argus HQ Research (2023). Medtronic Neuromodulation — Class II recall: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulator…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0354-2024
MLA
"Medtronic Neuromodulation — Class II recall: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulator…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0354-2024.
Chicago
Argus HQ Research. "Medtronic Neuromodulation — Class II recall: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulator…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0354-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medtronic_neuromodulation_z_0354_2024_2023,
title = {Medtronic Neuromodulation — Class II recall: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulator…},
author = {{Argus HQ Research}},
year = {2023},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0354-2024},
note = {Accessed: July 23, 2026}
}Informational only. Not legal, financial, or medical advice.