The Recall Desk
HighFDA (Devices)·Z-1819-2022·Announced 2022-10-05

VenaCure EVLT procedure kit fiber component fails dimensional specification

Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with a risk of procedural complications requiring device removal and potential additional surgical intervention, but no reported injuries or hospitalizations. Per the severity rubric, this qualifies as 'High' for being a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Angiodynamics, Inc. is recalling 40 units of VenaCure EVLT Procedure Kits (Catalog Number EVLT55OPS, Lot Number 5728621). This medical device is used in the treatment of varicose veins.

The OPS Fiber packaged within these specific kits does not meet the required dimensional specification. This defect may cause damage to the sheath, including separation or the inability to move the fiber within the sheath during the procedure.

If the sheath becomes damaged, it must be removed from the patient, which may result in procedural delay and/or the need for additional surgical intervention. The affected units were distributed to healthcare facilities across multiple U.S. states including Florida, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, Texas, and Virginia.

The recalled product

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.
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Vascular Treatment
Hazard
  • dimensional-defect
  • sheath-damage
  • procedural-complication

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621

Distribution

Distributed nationwide across the United States.

Related recalls

Same category