MEDTRONIC NEUROMODULATION FDA Inspection Record
MEDTRONIC NEUROMODULATION is an FDA-registered facility (FEI 2182207) located in Minneapolis, MN, US. RegDataLab tracks 15 FDA inspections and 2 compliance actions at this facility.
What FDA found at this site
- Latest inspection
- May 5, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 15 (2 OAI, 8 VAI, 5 NAI)
- Last OAI inspection
- Apr 3, 2013
- Warning letters
- 1 listed by FDA for this FEI, latest Jul 17, 2012
- Recalls as the recalling firm
- 70, latest Sep 8, 2026
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 5, 2023 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Investigation of device failures (21 CFR 820.198(c)) Time to report - 10 days (21 CFR 806.10(b)) Lack of System for Event Evaluations (21 CFR 803.17(a)(1)) |
| Nov 3, 2022 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Report of risk to health (21 CFR 806.10(a)(1)) |
| Sep 9, 2021 | No Action Indicated (NAI) | No citations listed |
| Oct 17, 2019 | Voluntary Action Indicated (VAI) | Design input - documentation (21 CFR 820.30(c)) Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Aug 6, 2019 | No Action Indicated (NAI) | No citations listed |
| Jun 21, 2018 | No Action Indicated (NAI) | No citations listed |
| Jun 30, 2017 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Investigation of device failures (21 CFR 820.198(c)) |
| Jun 7, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 26, 2015 | Voluntary Action Indicated (VAI) | Procedures not adequately established or maintained (21 CFR 820.40) Nonconforming product control (21 CFR 820.90(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) Report of risk to health (21 CFR 806.10(a)(1)) |
| Dec 19, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 8, 2026 | Class II | Z-0266-2027 | InterStim SureScan MRI Leads 978A1 & 978B1:
LEAD 978A128 ISTM MICRO 28CM SSMRI… and 1 more product Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as… |
| May 13, 2026 | Class II | Z-2240-2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator… and 1 more product A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. |
| Apr 8, 2026 | Class II | Z-2201-2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application… Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be… |
| Dec 3, 2025 | Class II | Z-1043-2026 | A71200 Vanta" Clinician Programmer Application (CP App) version
2.0.2465 and 2.0.2683… Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed… |
| Nov 20, 2025 | Class II | Z-0996-2026 | Restore Clinician Programmer Application (CP App), Model A71100 used with the following… Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to… |
| Apr 3, 2025 | Class II | Z-1704-2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior… |
| Mar 4, 2025 | Class II | Z-1543-2025 | Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv… There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific… |
| Jan 9, 2025 | Class II | Z-1506-2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion… Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable… |
| Nov 21, 2024 | Class II | Z-0771-2025 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG… and 3 more products Software issues were identified in application version 2.x. |
| Sep 24, 2024 | Class II | Z-0206-2025 | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician… |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Medtronic Neuromodulation
- Location
- Minneapolis, MN (US)
- Source
- device