A recall has been issued for the Medtronic Instrument Kit Fusion ENT. The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The Medtronic Instrument Kit includes Kit 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.
Medtronic sent an Urgent Medical Device Recall letter to all affected customers. Letters to foreign customers are being handled by geography-specific Regulatory Specialists. Customers were instructed to examine their inventory for the affected product and immediately quarantine them for return for Medtronic. Customers with affected product were instructed to contact Medtronic Technical Services
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