Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM — Class II medical device recall Z-3058-2017
Terminated recall by Medtronic Navigation, Inc., reported 2017-08-30, distributed nationwide. The instruments are not able to pass instrument verification which is performed prior to the use of each instr
| Recall number | Z-3058-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2017-06-29 |
| Classified | 2017-08-21 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2018-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 6 kits |
Product
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.