Medtronic recalls Stealth Autoguide Tracker model 28248 due to potential separation causing tissue injury during neurosurgery. Affected units include those in the Stealth Autoguide Basic Instrument Kit.
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.
Medtronic is recalling its Stealth Autoguide Tracker model 28248 because it may separate during surgery, leading to tissue injury. This recall affects instruments used in neurosurgical procedures.
The tracker may separate from the instrument tube during surgery, causing navigation inaccuracies. This could lead to prolonged procedures and tissue injury if the separation occurs.
Surgical teams using the Stealth Autoguide Basic Instrument Kit during neurosurgery are most at risk. The recall applies to all units sold with the model number 28248.
Check for the model number 28248 on the Stealth Autoguide Tracker. The product is part of the Stealth Autoguide Basic Instrument Kit (9736188) sold as a bundle with unique model numbers.
Look for the model number 28248 on the Stealth Autoguide Tracker.
Reach out to Medtronic for specific guidance on handling the recalled item.
The recall applies to surgical instruments used in neurosurgery. If you have the model 28248 tracker, contact Medtronic for instructions.
The Bundle Autoguide Reg Kit is an internal sales configuration that includes the tracker and instrument kit with unique model numbers. It does not affect customers directly.
The recall requires checking the model number and contacting Medtronic for specific guidance, not immediate discontinuation.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0417-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0417-2022 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
