CLASS II ONGOING Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
Stealth Autoguide Tracker recalled by Medtronic Navigation
Medtronic Navigation is recalling Stealth Autoguide Tracker, distributed in 21 states. The recall was initiated on 9 Nov 2021 and the FDA has classified it as Class II.
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-0417-2022
- FDA event ID
- 89074
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Nov 2021
- FDA classified
- 22 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Nov 2021 | Recall initiated by company | |
| 22 Dec 2021 | Classified by FDA | +43 days |
| 29 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
Where it was distributed
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
ArizonaCaliforniaFloridaIllinoisIndianaKansasKentuckyMichiganMinnesotaMissouriMississippiNebraskaNevadaOhioOklahomaOregonSouth CarolinaTexasUtahVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All lot numbers
Where was it sold?
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
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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