Recall archive / FDA device enforcement
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: ... — FDA record Z-0417-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 9, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
- Reason
- A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.
- Classification
- Class II
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 98
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0417-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lot numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT, MS, VA, SC. OUS: Canada, Sweden, Italy, France, Germany, Spain, Czech Republic, United Kingdom, India, Nepal, Japan, Turkey, China
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 29, 2021
- Recall initiation date
- Nov 9, 2021
- Center classification date
- Dec 22, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.