Recall Z-1819-2022— Angiodynamics, Inc.

Name: FDA recall Z-1819-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-10

Class II · Ongoing

Class II FDA medical device recall by Angiodynamics, Inc., initiated 2022-08-10. It names one FDA 510(k) clearance: K041957. 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.. 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.

Recalling firm: Angiodynamics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-10
Firm location: Queensbury, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K041957 — EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERSDiomed, Inc.·cleared 2004-12-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.