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.
Check against the official notice below — it lists the full affected range.
AngioDynamics, Inc. is recalling VenaCure EVLT Kits with Spotlight OPS Sheath 55cm used to treat varicose veins. The OPS Fiber in certain kits does not meet required dimensional specifications, which may cause damage to the sheath, including separation or prevent the fiber from moving within the sheath. If the sheath becomes damaged, it must be removed from the patient, potentially causing procedural delays or requiring surgical intervention.
The recall affects 40 units distributed nationwide in Florida, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, Texas, and Virginia. The affected kits have UPN H787EVLT55OPS5 and Lot Number 5728621. The source document does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA. Quantity: 40 units Lot/code info: UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.