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ScleroSafe

V.V.T. MED LTD · Model 350 · UDI-DI 07290013043092

KRA FMF

510(k) clearances

9,137

Adverse events (366 deaths)

137

Recalls

150

Facilities

Description

ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (DPS) is intended for the delivery of Asclera®, an FDA-approved sclerosant, in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm. ScleroSafe is a sterile, single use device. The Catheter is packaged in a tray which includes all the accessories required for percutaneous introduction using the micropuncture technique. The catheter length is 350mm and is a 5F dual lumen with tapered - tip and two sets of Luer nozzles. ScleroSafe consists of the following components: Micro puncture needle, Nitinol guidewire and plastic torque tool, Dual Lumen Catheter, and Dual procedure syringes (DPS)to allow simultaneous withdrawal of blood and administration of fluids.

Recalls

Date	Firm	Reason
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.