Recall Z-1666-2023 · HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
| Date | Jun 2, 2023 (initiated Apr 11, 2023) |
| Status | Open, Classified |
| Reason | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury |
| Root cause | Software design |
| Action | On 4/11/23, "URGENT: MEDICAL DEVICE CORRECTION" notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the Distance to/past Target value for Tumor Resection, Shunt Placement, and DBS procedures. Per the IFU: "Warning: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient." and "If system navigation |
| Quantity | 556 |
| Distribution | US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREEC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150216 | Synergy Cranial Medtronic Navigation, Inc., Jun 11, 2015 |
| K153660 | StealthStation System with Cranial Software Medtronic Navigation, Inc., Sep 14, 2016 |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Medtronic Navigation, Inc., Jul 31, 2019 |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 Medtronic Navigation, Inc., Jun 10, 2022 |