Medtronic Navigation, Inc. recalls StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is…
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing…
Read the official notice →- Date
- 2024-10-16
- Country
- United States
- Brand
- Medtronic Navigation
- Product
- StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is…
- Classification
- Class II
- Units
- Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Navigation recalls
- 2025-02-05
USMedtronic Navigation, Inc. recalls Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile…
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →- 2024-05-15
- US
Medtronic Navigation, Inc. recalls Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating…
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
FDA · DeviceMedtronic Navigation, Inc.Worldwide distribution. US nationwide including Puerto Rico, Argentina,…Official notice → - 2024-01-17
- US
Medtronic Navigation, Inc. recalls Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the…Official notice → - 2023-11-15
- US
Medtronic Navigation, Inc. recalls StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is…
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - 2023-06-14
- US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
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…
FDA · DeviceMedtronic Navigation, Inc.US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA,…Official notice → - US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information…
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-16
- US
Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube…
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues,…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the state of CA.Official notice → - US
AURIS HEALTH INC recalls Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure…
FDA · DeviceAURIS HEALTH INCWorldwide - US Nationwide distribution including in the states of MN, FL, NC,…Official notice → - US
Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to…
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
FDA · DeviceCook IncorporatedInternational distribution to the country of Australia.Official notice → - US
Howmedica Osteonics Corp. recalls MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Germany.Official notice → - US
Luminex Molecular Diagnostics Inc recalls NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that…
FDA · DeviceLuminex Molecular Diagnostics IncU Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO,…Official notice →