CLASS I Device recall · Reported 27 May 2020 · FDA Enforcement Report
Medtronic Nexframe Stereotactic System and StealthStation Cranial recalled
Medtronic Navigation is recalling Medtronic Nexframe Stereotactic System and StealthStation Cranial, distributed nationwide in the US. The recall was initiated on 9 Aug 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1995-2020
- FDA event ID
- 85243
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Aug 2019
- FDA classified
- 18 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 9 Aug 2019 | Recall initiated by company | |
| 18 May 2020 | Classified by FDA | +283 days |
| 27 May 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
Product as listed by the FDA
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
Where it was distributed
Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.
Questions about this recall
Why was it recalled?
Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
Which lots are affected?
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS procedure. Stealthware Station Cranial Software GTIN(s): 00643169878204, 00643169625549 O-Arm Imaging System GTIN(s): 00763000068073, 00763000068080, 00763000068097, 00763000068103, 00763000074050, 00763000074067, 00763000074074, 00763000074081, 00763000074098, 00763000074104, 00763000074111, 00763000074128, 00763000074135, 00763000079000, 00763000079017, 00763000079024, 00763000079031, 00763000079048, 00763000079055, 00763000079062, 00763000079079, 00763000079086, 00763000079093, 00763000079109, 00763000079215, 00763000079246, 00763000079260, 00763000080969, 00763000080976, 00763000080983, 00763000080990, 00763000081003, 00763000081010, 00763000081027, 00763000081034, 00763000081041, 00763000081058, 00763000081065, 00763000081072, 00763000081089, 00763000081096 and 00763000081102. Nexframe Stereotactic System GTIN(s): DB-2040, 00643169214811; MI-1000, 00643169986763; MI-2000, 00643169986770; NP-1000, 00613994747877.
Where was it sold?
Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Navigation
All 92| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation | Medtronic Navigation | Other | Nationwide |
| Device | CLASS II | StealthStation S8 App versions 1.3.0 and 1.3.2 recalled | Medtronic Navigation | Device Malfunction | Nationwide |
| Device | CLASS I | Stealth S8 Clinical recalled by Medtronic Navigation | Medtronic Navigation | Device Malfunction | Nationwide |
| Device | CLASS II | Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled | Medtronic Navigation | Other | Nationwide |
| Device | CLASS II | Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled | Medtronic Navigation | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |