• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Set Supplemental INS AxiEM ENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medtronic Set Supplemental INS AxiEM ENTsee related information
Date Initiated by FirmJune 29, 2017
Create DateAugust 21, 2017
Recall Status1 Terminated 3 on August 03, 2018
Recall NumberZ-3057-2017
Recall Event ID 77739
510(K)NumberK153555 
Product Classification Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
ProductMedtronic 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
Code Information Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information ContactTom F. Reimann
720-890-3241
Manufacturer Reason
for Recall
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
FDA Determined
Cause 2
Device Design
ActionMedtronic sent an Urgent Medical Device Recall letter dated June 25, 2017, via overnight mail on June 29, 2017, to all affected customers. Letters to foreign customers are being handled by geography-specific Regulatory Specialists. Customers were instructed 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 at 1-800-595-9709 to receive a return material authorization (RMA) and arrange for their return and no charge replacements. Customers were asked to complete and follow instructions on the attached Consignee Response Form. Sign and date the bottom of the form and then return the form to Medtronic at RS NavFCA@medtronic.com or fax it to Medtronic Technical Services at 651-367-7075. Customers with questions were instructed to call 1-800-595-9709.
Quantity in Commerce8 kits
DistributionWorldwide Distribution - US (nationwide) and Internationally to Canada.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PGW
-
-