Z-0417-2022Class II

Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument...

Name: Z-0417-2022 Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument...
Creator: Medtronic Navigation, Inc.
Published: 2021-11-09
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2021-11-09 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit on 2021-11-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0417-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-09
Posted: 2021-12-22
Recalling firm: Medtronic Navigation, Inc
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/09/21, recall notices were distributed to healthcare professionals. The firm requested the following actions: 1) Identify, segregate, and quarantine affected products within your inventory. 2) Complete and return the Customer Confirmation Form even if you do not have inventory. The Customer Confirmation Form must be returned to initiate the Return Good Authorization (RGA) process. The RGA will be provided to you upon Medtronic receipt and processing of the Customer Confirmation Form. 3) Upon customer receipt of the RGA, return the affected product as instructed in the RGA. 4) This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 5) Maintain a copy of this notice in your records. Customers with questions are encouraged to call: 1-888-826-5603. The recalling firm is working with its suppliers to make inventory available as soon as possible at which point a replacement device will be provided at no additional cost. Until replacement product is available, navigated alternatives can be used.
Quantity in commerce: 98
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
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0417-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0417-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-22

Product code HAW

K191597Class IIStealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. / cleared 2019-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)