🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: August 10, 2022 Angiodynamics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Angiodynamics, Inc.
Reason for Recall:
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1819-2022

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