| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00861-1 |
| Product Name/Description |
Multiple AxiEM ENT Suction Instruments
Straight Suction EM, ENT
Curved Suction 70 EM,
Short Curved Suction 90, EM
Suction Small Straight AxiEM ENT
Multiple Part and Lot Numbers
These instruments may also be included in the following kits:
ENT Instrument Set
Fusion ENT Instrument Kit
ENT AxiEM Instrument Set
ENT Prgm Add Fusion Nav AxiEM
ARTG Numbers: 129428, 125074 & 120114 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has become aware that the specific lots of AxiEM ENT Suction Instruments are not able to pass instrument verification. Instrument verification is a step in the software which is performed prior to the use of each instrument. This verification step confirms device tracking functionality and prevents use of the device if a passing verification is not achieved. The impacted devices were made with a particular stainless steel stock material that exhibits magnetic characteristics (magnetic permeability), causing interference with electromagnetic (EM) tracking capability of the StealthStation.
If this issue presents during surgery, it may result in surgery being extended to troubleshoot the issue, discontinuation of navigation, or aborting surgery if alternative instruments are not available to proceed. To date, there have been no reports of patient injury. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requesting customers examine their inventory and if any of the affected products listed in the customer letter are found, immediately cease use and quarantine them for return to Medtronic. Alternatively, each local Medtronic Sales Representative will perform this step. If the product has been removed from its original packaging, the part number and lot number can be found printed directly on the device as shown in the pictures given in the customer letter.
This action has been closed out on 26/02/2019 |
| Contact Information |
02 9857 9000 - Medtronic |