Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-1819-2022

August 10, 2022

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 90811
Status
Ongoing
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-1819-2022

Official wording

Reason: 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

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

Distribution pattern: US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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