Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog Recalled by Angiodynamics, Inc. Due to OPS Fiber packaged within specific VenaCure EVLT Procedure...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Angiodynamics, Inc. directly.
Affected Products
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
Quantity: 40 units
Why Was This Recalled?
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 the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Angiodynamics, Inc.
Angiodynamics, Inc. has 74 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report