Z-0715-2011

Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation...

Name: Z-0715-2011 Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation...
Creator: Medtronic Navigation, Inc
Published: 2010-11-05
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-11-05 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc began a recall of Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely... on 2010-11-05. The reason FDA records is "Electronic surgical navigation aid may lose tracking ability or stop working". 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-0715-2011
Status: Terminated
Initiated: 2010-11-05
Posted: 2010-12-17
Terminated: 2011-05-03
Recalling firm: Medtronic Navigation, Inc
Product: Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Electronic surgical navigation aid may lose tracking ability or stop working.
Root cause tag: design
FDA root cause: Component design/selection
Action: Customers were notified by a Product Correction Notification letter on 11/05/2010. The letter advised customers of the affected product, the potential problem, and the description of the correction. Customers were told that a Medtronic rep will visit them to install a replacement control unit. Further information is available at 800-595-9709 or 720-890-3200.
Quantity in commerce: 48 devices
Distribution: Worldwide Distribution -- US, including states of AL, AZ, CO, FL, GA, KY, MD, MN, NE, PA, TX, WI, and MD and countries of Australia, Belgium, Canada, Czech Republic, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Turkey, and UAE.
Product codes and lots: Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010.

Product code HAW

K050438Class IIStealthstation System UpdateMedtronic Surgical Navigation Technologies / cleared 2005-06-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)