Z-2029-2010

Medtronic StealthStation S7 System

Name: Z-2029-2010 Medtronic StealthStation S7 System
Creator: Medtronic Navigation, Inc
Published: 2010-06-14
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-06-14 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc began a recall of Medtronic StealthStation S7 System on 2010-06-14. The reason FDA records is "Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock". 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-2029-2010
Status: Terminated
Initiated: 2010-06-14
Posted: 2010-07-17
Terminated: 2011-02-18
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic StealthStation S7 System
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were notified by letter on Jun 14, 2010, advising them of the problem. Instructions were provided to continue using existing retractable power cords until they could be replaced with non-retractable cords by Medtronic, beginning on Aug 17. Further information is available from the company by calling 800-595-9709.
Quantity in commerce: 370 units
Distribution: Nationwide, including 3 VA facilities. No military distribution. Foreign accounts in Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, New Zealand, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United Arab Emirates.
Product codes and lots: All lots.

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)