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Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308,...

FDA Device Recall #Z-3057-2017 — Class II — June 29, 2017

Recall Summary

Recall Number Z-3057-2017
Classification Class II — Moderate risk
Date Initiated June 29, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Navigation, Inc.
Location Louisville, CO
Product Type Devices
Quantity 8 kits

Product Description

Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Reason for Recall

The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Lot / Code Information

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Other Recalls from Medtronic Navigation, Inc.

Recall # Classification Product Date
Z-1022-2025 Class II Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: ... Dec 4, 2024
Z-0050-2025 Class II StealthStation S8 App versions 1.3.0 and 1.3.2,... Aug 22, 2024
Z-1776-2024 Class I Stealth S8 Clinical Software Application, REF: ... Mar 26, 2024
Z-0698-2024 Class II Medtronic, REF 9733235, Pin, 100mm, STERILE, PE... Nov 28, 2023
Z-0699-2024 Class II Medtronic, REF 9733236, Pin, 150mm, STERILE, PE... Nov 28, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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