Angiodynamics recalls VenaCure EVLT Procedure Kits with Spotlight Ops Sheath 55cm (EVLT55OPS) due to potential sheath damage causing procedural delays or surgery. Affected kits have specific UDI-DI and lot numbers.
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
Angiodynamics is recalling VenaCure EVLT Procedure Kits with Spotlight Ops Sheath 55cm (EVLT55OPS) because the fiber packaging may cause sheath damage. This could lead to needing to remove the device from the patient, causing delays or additional surgery.
The fiber packaging in the kit may not meet dimensional specifications, causing the sheath to separate or become unable to move the fiber. If the sheath is damaged, it must be removed from the patient, which could delay the procedure or require additional surgery.
Healthcare providers using the VenaCure EVLT Procedure Kits with Spotlight Ops Sheath 55cm (EVLT55OPS) for varicose vein treatment are most at risk. Patients undergoing the procedure may face procedural delays or additional surgery if the sheath is damaged.
Check for the product name 'VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM' and catalog number EVLT55OPS. Each box contains 5 Procedure Kits. The UDI-DI is 25051684014653 and lot number 5728621.
Identify the product by catalog number EVLT55OPS or UDI-DI 25051684014653.
The fiber packaging may not meet dimensional specifications, causing sheath damage that could lead to procedural delays or additional surgery.
The recall record does not specify a remedy, so contact Angiodynamics directly for guidance.
Yes, if the sheath is damaged during use, it may require removal from the patient, causing procedural delays or additional surgery.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1819-2022 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1819-2022 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
