Angiodynamics, Inc. recalls VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the…
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within…
Read the official notice →- Date
- 2022-10-05
- Country
- United States
- Brand
- Angiodynamics
- Product
- VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the…
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ,…Official notice →- 2024-02-14
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Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
FDA · DeviceAngiodynamics, Inc.United States (MD, LA & UT), Austria, Canada and Spain.Official notice → - 2023-04-19
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Angiodynamics, Inc. recalls NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN:…
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
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Angiodynamics, Inc. recalls Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement…
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, CA, DC, IN, PA.Official notice → - 2021-10-13
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Angiodynamics, Inc. recalls AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID…
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
FDA · DeviceAngiodynamics, Inc.Internationally distribution to the countries of Australia, Germany, Denmark,…Official notice → - 2021-10-06
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term…
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Other drugs & medical recalls in the United States
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