FDA recall Z-1819-2022

Angiodynamics, Inc. · Class II · 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.

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.

Key facts

Status
Ongoing
Initiation date
2022-08-10
Report date
2022-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1819-2022