Medtronic Navigation, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1584-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ENT PRGM 9734636 ADD FUSION NAV AxiEM

Product Classification:

Class II

Date Initiated: April 24, 2014

Date Posted: November 26, 2014

Recall Number: Z-1584-2014

Event ID: 68145

Reason for Recall:

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Status: Terminated

Product Quantity: 26,674 total

Code Information:

Lot No.: 6917614

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated