SynergyCranialRecalls & reported problems across all models
Medtronic Navigation, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 6 models of SynergyCranial by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
SynergyCranial recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 26, 2018Terminated
An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
Z-0552-2019 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗
SynergyCranial models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Synergy®Cranial 9734068Neurological stereotaxic Instrument1 recall0 reports
- Synergy®Cranial 9733763Neurological stereotaxic Instrument1 recall0 reports
- Synergy®Cranial 9734068Neurological stereotaxic Instrument1 recall0 reports
- Synergy®Cranial 9734068Neurological stereotaxic Instrument1 recall0 reports
- Synergy®Cranial 9734068Neurological stereotaxic Instrument1 recall0 reports
- Synergy®Cranial 9734068Neurological stereotaxic Instrument1 recall0 reports
Other Medtronic Navigation, Inc. products
- O-ARM17 models · 9,235 reports · 5 recalls
- StealthStation S8 Platform14 models · 8,402 reports
- Stealthstation S711 models · 5,756 reports
- StealthStation S86 models · 2,235 reports
- Fusion ENT Image Guidance System5 models · 2,033 reports
- Visualase25 models · 625 reports · 3 recalls
- NavLock9 models · 134 reports · 1 recall
- AxiEM12 models · 62 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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