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Recall Observatory FDA recall evidence

Device product

Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 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

Z-3055-2017

June 29, 2017

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 77739
Status
Terminated
Classification
Class II
Quantity
13 kits
Official record key
device-enforcement:Z-3055-2017

Official wording

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

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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