Medtronic Navigation, Inc. recalls Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the…
A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy…
Read the official notice →- Date
- 2021-12-29
- Country
- United States
- Brand
- Medtronic Navigation
- Product
- Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the…
- Classification
- Class II
- Units
- US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
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
- 2023-06-14
USMedtronic 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 → - 2023-02-08
- US
Medtronic Navigation, Inc. recalls AxiEM" Non-Invasive Patient Tracker
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO,…Official notice → - 2023-01-18
- US
Medtronic Navigation, Inc. recalls RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
FDA · DeviceMedtronic Navigation, Inc.US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN,…Official notice → - 2022-11-23
- US
Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue…
Due to a defect in the outer pouch sterile seal
FDA · DeviceMedtronic Navigation, Inc.U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL,…Official notice → - 2021-12-29
- US
Medtronic Navigation, Inc. recalls Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model:…
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy…
FDA · DeviceMedtronic Navigation, Inc.US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL,…Official notice →
Other drugs & medical recalls in the United States
- 2022-01-05
- US
Teligent Pharma, Inc. recalls Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC…
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
- US
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent…
Superpotent Drug: Minimally superpotent
FDA · DrugTeligent Pharma, Inc.Distributed to a wholesaler in CO who further distributed Nationwide in the USAOfficial notice → - US
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent…
Superpotent Drug
FDA · DrugTeligent Pharma, Inc.Distributed to a wholesaler in CO who further distributed Nationwide in the USAOfficial notice → - 2021-12-29
- US
Philips North America Llc recalls Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging…
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide distribution in the states of DC, GA,…Official notice → - US
Acclarent, Inc. recalls TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy…
FDA · DeviceAcclarent, Inc.US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV,…Official notice → - US
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice →