Z-1007-2017Class II

AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid...

Name: Z-1007-2017 AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid...
Creator: Medtronic Navigation, Inc.
Published: 2016-12-12
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-12-12 / Terminated

FDA source

Medtronic Navigation, Inc. began a recall of AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton on 2016-12-12. FDA classified it as Class II and gives the reason as "Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation System with...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1007-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Posted: 2017-01-11
Terminated: 2017-05-19
Recalling firm: Medtronic Navigation, Inc
Product: AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation System with Touch N Go Pointer Probes for patient registration.
FDA root cause: Process change control
Action: The firm, Medtronic, sent an "URGENT: MEDICAL DEVICE RECALL" letter on 12/12/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for any affected products, quarantine them for return to Medtronic; complete and return the CUSTOMER RESPONSE FORM by email at [email protected] or fax to Medtronic Technical Services at 651-367-7075 (even if you do not have affected product); and contact Medtronic Technical Services at 1-800-595-9709 to get a return material authorization (RMA) and arrange for their return and no charge replacements. If you have any questions regarding this communication, please contact Medtronic Technical Services at (800) 595-9709.
Quantity in commerce: 111 devices
Distribution: US Nationwide Distribution.
Product codes and lots: lot number 150626B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1007-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1007-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code HAW

K141833Class IIStylet, 23Cm, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-N-Go Pointer, NavigationMedtronic Navigation, Inc. / cleared 2015-03-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)