Medtronic Navigation, Inc. recalls Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction

Recalled August 30, 2017 · FDA recall Z-3057-2017 · Medtronic Navigation

Hazard

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

Units

8 kits

Sold at

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

Description

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

Product

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

Manufacturer(s)

Medtronic Navigation, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →