StealthStation S8 Platform 9735665 (UDI 00763000359881)Recalls & reported problems
Medtronic Navigation, Inc. · MAIN CART 9735665 STEALTH S8 PREMIUM · Class 2
Quick summary
This Medtronic StealthStation S8 surgical navigation system has 1,884 adverse event reports on record, including 1 death and 51 injuries. Many reports describe software problems, such as the application freezing or failing to launch, incorrect readings, and display problems. Reports fell to 209 in the last 12 months, from 534 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,896
- Deaths reported
- 1
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,896 adverse event reports that list this exact device (DI 00763000359881), received between Mar 17, 2021 and Sep 29, 2026 — classified as 1 death, 53 injuries, 1,842 malfunctions.
The most frequently reported specific device problem is “Application Program Problem” (415 reports).
2 other recalls cover devices cleared under the same FDA submission (K162309); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Application Program Problem415
- Incorrect, Inadequate or Imprecise Result or Readings389
- Application Program Freezes or Fails to Launch287
- Mechanical Problem262
- Display or Visual Feedback Problem245
- Device Sensing Problem223
- Communication or Transmission Problem189
- Imprecision173
Patient problems
- No Clinical Signs, Symptoms or Conditions1,867
- Unspecified Tissue Injury21
- Insufficient Information6
- Hemorrhage/Blood Loss/Bleeding5
- Muscle Weakness/Atrophy3
- Cerebrospinal Fluid Leakage2
- Nerve Damage2
- Spinal Cord Injury2
Recent adverse event reports
The 25 most recent of 1,896 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934579 ↗MalfunctionSep 25, 2026Positioning Problem
Medtronic received information regarding a navigation system being used during a cranial biopsy procedure. It was reported that automated trajectory guidance unit was unable to lock into target. The unit only showed the dashed circle Indicating there was no reachability information available. A Manufacturer Representative (rep) confirmed the IP address and communication between navigation system and targeting unit, the Tool verified. They were in the Navigation task on the system and the Surgical plan was available. The unit was in home position after gross positioning. There was a delay of less than 1 hour and no impact on patient outcome reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900144 ↗InjurySep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889604 ↗MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Naturally Worn
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that after performing a planned maintenance on the system, the systems power cable was found to have wear and tear and the interconnect cable had a cut through it. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884196 ↗MalfunctionSep 23, 2026Communication or Transmission Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866865 ↗MalfunctionSep 21, 2026Communication or Transmission Problem; Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847570 ↗MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843201 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Medtronic received information regarding a navigation system being used in an unknown procedure. It was reported that the surgeon claimed navigation was inaccurate. The extent of surgical delay (if any) is unknown. The impact on patient outcome is unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820384 ↗MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779702 ↗MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776721 ↗MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure. It was reported that all instruments appeared to have an alleged 1 cm deep inaccuracy. The instruments in use were the thoracic probe, awl tip tap, and screwdriver. It was also noted that screw placement was not towards or away from the frame. A respin resolved the issue. There was no surgical delay or impact on patient outcome.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766457 ↗MalfunctionSep 14, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763300 ↗MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756893 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722715 ↗MalfunctionSep 9, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700015 ↗MalfunctionSep 9, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693623 ↗MalfunctionSep 2, 2026Display or Visual Feedback Problem; Mechanical Problem; Connection Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570798 ↗MalfunctionSep 2, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568781 ↗MalfunctionSep 2, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554679 ↗InjurySep 1, 2026Incorrect, Inadequate or Imprecise Result or Readings
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure. It was reported that there was an alleged inaccuracy. During an oblique lumbar interbody fusion (OLIF) on L2-L3, they used the left side of the navigation system to take a navigated spin and the screw went into the canal on L2 which may have paralyzed the patient. When they took the screw out, the patient reportedly "almost jumped off the table." They switched to an open posterior procedure and re-spun using the right imaging system trackers and reported everything appeared to be accurate. This issue caused a 45-minute surgical delay. No additional information regarding the patient's outcome was reported.
Patient problems: Paralysis
MAUDE report 50550488 ↗MalfunctionAug 27, 2026Mechanical Problem; Application Program Problem
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the system was displaying "Localizer Faulted". There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483794 ↗MalfunctionAug 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456396 ↗MalfunctionAug 26, 2026Mechanical Problem; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456153 ↗MalfunctionAug 24, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412945 ↗MalfunctionAug 12, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223632 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162309. One submission often covers many models, so check the product and lot details in each record.
- Z-1776-2024 · Mar 26, 2024 · Open, ClassifiedStealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutane
- Z-1995-2020 · Aug 9, 2019 · TerminatedMedtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen
Other Neurological stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
- Fusion™ ENT Image Guidance System 9733560Medtronic Navigation, Inc. · Neurological stereotaxic Instrument458 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.