Medtronic Navigation, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3051-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. 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

Product Classification:

Class II

Date Initiated: June 29, 2017

Date Posted: August 30, 2017

Recall Number: Z-3051-2017

Event ID: 77739

Reason for Recall:

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

Status: Terminated

Product Quantity: 277 instruments

Code Information:

Lot numbers 17022809, 17030108,17022207,17022106, 17020805, 17020904, 17021798,17020987, 17011896, 17011221, 17011220, 16122237, 16122236, 16121661,16121260, 16121259, and 16112958

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated