—#182108

Product

StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K133444
Affected lot / code info: StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896; and StealthStation S7 Serial Number N07308697 with Polaris Spectra Camera Serial Number P7-18852.

Why it was recalled

There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Urgent Medical Device Correction Letters were emailed to customers on June 5, 2020. Emails were followed by Medtronic representatives hand-delivering the recall notification letter as well as the customer confirmation form to the two affected consignees on June 12, 2020. Customers were informed that there is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. Customers were informed that their local Medtronic representative would work with them to remove and replace the affected camera on your impacted system. Customers were informed that Medtronic has not identified any complaints or reports of injury related to this issue. However, if impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm. Customers were requested to not use the affected StealthStation" S7 System unit for simultaneous active and passive navigation (such as active instrumentation, active reference frames, or a navigated microscope) until the camera is replaced on this system; to work with their Medtronic representative to replace the camera on their impacted system; and to sign and return the enclosed customer confirmation form, acknowledging receipt of this information.Customers were notified that Medtronic is communicating this information to the Food and Drug Administration (FDA). Adverse events or quality problems experienced with this product should be reported to FDA and Medtronic: Online at the FDA website (www.fda.gov) or call FDA at 1-800-FDA-1088 and via E-mail to Medtronic at rs.navtechsupport@medtronic.com or by calling 1-888-826-5603. Customers with any questions regarding the urgent medical device correction should contact Medtronic Technical Services at 1-888-826-5603.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: US Nationwide distribution including in the states of Alabama and Massachusetts.

Timeline

Recall initiated: 2020-06-05
Terminated: 2024-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.