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U.S. Department of Health and Human Services

Class 1 Device Recall StealthStation DBS Software Nexframe AutoRegistration

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 Class 1 Device Recall StealthStation DBS Software Nexframe AutoRegistrationsee related information
Date Initiated by FirmAugust 09, 2019
Date PostedMay 18, 2020
Recall Status1 Terminated 3 on April 02, 2024
Recall NumberZ-1995-2020
Recall Event ID 85243
510(K)NumberK153660 K162309 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductMedtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
Code Information Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS procedure.  Stealthware Station Cranial Software GTIN(s): 00643169878204, 00643169625549  O-Arm Imaging System GTIN(s): 00763000068073, 00763000068080, 00763000068097, 00763000068103, 00763000074050, 00763000074067, 00763000074074, 00763000074081, 00763000074098, 00763000074104, 00763000074111, 00763000074128, 00763000074135, 00763000079000, 00763000079017, 00763000079024, 00763000079031, 00763000079048, 00763000079055, 00763000079062, 00763000079079, 00763000079086, 00763000079093, 00763000079109, 00763000079215, 00763000079246, 00763000079260, 00763000080969, 00763000080976, 00763000080983, 00763000080990, 00763000081003, 00763000081010, 00763000081027, 00763000081034, 00763000081041, 00763000081058, 00763000081065, 00763000081072, 00763000081089, 00763000081096 and 00763000081102.  Nexframe Stereotactic System GTIN(s): DB-2040, 00643169214811; MI-1000, 00643169986763; MI-2000, 00643169986770; NP-1000, 00613994747877.
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
720-890-3200
Manufacturer Reason
for Recall
Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
FDA Determined
Cause 2
Software design
ActionUrgent Medical Device Correction Letters were sent to U.S. customers via FedEx Overnight with signature required at delivery beginning on August 9, 2019. European consignees were first notified via registered mail and/or personal visits by Medtronic representatives starting August 27, 2019. The one Canadian consignee was first notified via registered mail starting August 19, 2019. Customers were informed of which devices, when used in combination, can result in entry point and lead placement inaccuracies during Deep Brain Stimulation (DBS) lead implantation procedures. Customers were instructed to: 1. determine which registration method, auto-registration (fiducial-less) or manual registration, is appropriate considering the information in the Urgent Medical Device Correction Letter, 2. assess navigational accuracy on several known anatomical landmarks before using the registration for navigation, 3. use the StealthMerge functionality in the software to compare the actual location of the cannula or lead to the surgical plan, 4. use the planning functionality in the software to compare the cannula to planned trajectory, 5) sign and date the Customer Confirmation Form, and return the form to Medtronic via email at RS.NavFCA@Medtronic.com or via fax at 651-367-7075 within 30 days of receipt. Neurosurgeon users were informed that a Medtronic representative would contact them regarding training available to provide an overview of this issue. Users were requested to register for and complete the training. Customers were instructed to report adverse events or quality problems experienced with the product to FDA and Medtronic as follows: E-mail Medtronic at rs.navtechsupport@medtronic.com or call 1-888-826-5603; Online at the FDA website2 (form available to fax or mail) or call FDA at 1-800-FDA-1088. Customers with questions were instructed to contact Medtronic at 1- 888-826-5603.
Quantity in Commerce61 customers purchased the specified combination of equipment which may lead to this error.
DistributionWorldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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