Z-3057-2017Class II

Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small...

Name: Z-3057-2017 Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small...
Creator: Medtronic Navigation, Inc.
Published: 2017-06-29
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2017-06-29 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is... on 2017-06-29. FDA classified it as Class II and gives the reason as "The instruments are not able to pass instrument verification which is performed prior to the use of each instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3057-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Posted: 2017-08-21
Terminated: 2018-08-03
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic 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
Product code: PGW Ear, Nose, And Throat Stereotaxic Instrument
Reason for recall: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic 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 [email protected] or fax it to Medtronic Technical Services at 651-367-7075. Customers with questions were instructed to call 1-800-595-9709.
Quantity in commerce: 8 kits
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3057-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3051-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3052-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3053-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3054-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3055-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3056-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3057-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3058-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21

Product code PGW

K153555Class IIEM ENT Navigated SuctionsMedtronic Navigation, Inc. / cleared 2016-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)