Angiodynamics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1819-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: August 10, 2022

Date Posted: October 5, 2022

Recall Number: Z-1819-2022

Event ID: 90811

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

Status: Ongoing

Product Quantity: 40 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated