Medtronic Navigation, Inc.: Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.

Recall number

Z-0417-2022

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.

Status

Open, Classified

Initiated

2021-11-09

Posted

not on file

Terminated

not on file

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.

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

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

Lot, serial or model codes

All lot numbers

510(k) numbers

["K191597"]

PMA numbers

not on file

Product code

HAW

Firm FEI

1000517638

Firm city

Louisville

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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