Stealth Autoguide Tracker — Class II medical device recall Z-0417-2022
Ongoing recall by Medtronic Navigation, Inc., reported 2021-12-29, distributed in AZ, CA, FL, IL, IN, KS, KY, MI…. A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure,
| Recall number | Z-0417-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2021-11-09 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Distributed | AZ, CA, FL, IL, IN, KS, KY, MI, MN, MO, MS, NE, NV, OH, OK, OR, SC, TX, UT, VA, WA |
| Countries outside the US | CA, CN, CZ, DE, ES, FR, GB, IN, IT, JP, NP, SE, TR |
| Quantity | 98 |
| Reason classes | labeling |
| Model numbers | 28248 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0417-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.