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RobotRisk / Medtronic Hugo / 2026-09

FDA MAUDE record 2020-2026: 0 death, 39 injury, 1594 malfunction reports

S4 · 09/2026 · Medtronic Hugo

Record

CompanyMedtronic Hugo
Categorymedical robotics
Typeregulatory
Date09/2026
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS4 (serious injury, total loss, or grounding)
Scale1633 reports
Confidencehigh
VerificationCited source on file; not independently re-verified
SourceopenFDA MAUDE

What happened

openFDA MAUDE adverse-event reports since 2020 for the Hugo platform: 0 death, 39 injury, 1594 malfunction reports. Aggregate regulatory record; MAUDE reports are unverified submissions and include user error.

This is an aggregate regulatory record summarizing a regulator database, not a single event; it is refreshed from the source on every update cycle.

Medtronic Hugo record context

Entries by year and severity

14272020 S3: 11202021 S3: 33212022 S3: 33222024 S3: 22242025 S3: 44252026 S3: 262026 S4: 12726
S1S2S3S4S5

By incident type

By severity

Medtronic Hugo vs medical robotics alternatives

medical robotics context

medical robotics: entries by year

2545082015 S2: 12015 S3: 12152016 S3: 32016 S4: 14162017 S4: 11172018 S2: 12018 S3: 12182019 S3: 33192020 S3: 1052020 S5: 3108202021 S3: 1642021 S4: 12021 S5: 3168212022 S2: 12022 S3: 1352022 S5: 10146222023 S3: 2222023 S5: 2224232024 S3: 2692024 S5: 7276242025 S3: 5042025 S5: 4508252026 S1: 12026 S2: 12026 S3: 4262026 S4: 52026 S5: 844126
S1S2S3S4S5

medical robotics: failure modes

medical robotics: most entries

regulatory context

regulatory: by category

regulatory: by year

regulatory: severity profile

Comparable regulatory events in medical robotics

SevDateCompanyEvent
S42026-09Stryker MakoFDA MAUDE record 2020-2026: 0 death, 132 injury, 322 malfunction reports
S52026-09Intuitive SurgicalFDA MAUDE record 2020-2026: 35 death, 1615 injury, 2388 malfunction reports
S42026-09CMR SurgicalFDA MAUDE record 2020-2026: 0 death, 3 injury, 186 malfunction reports
S42026-09Asensus SurgicalFDA MAUDE record 2020-2026: 0 death, 15 injury, 13 malfunction reports
S32024-08-13Globus MedicalFDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot

Other Medtronic Hugo entries

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