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SclereSafe

V.V.T. MED LTD · Model 150 · UDI-DI 07290013043085

KRA FMF

510(k) clearances

9,056

Adverse events (362 deaths)

Recalls

148

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 150mm 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
2023-12-18	Angiodynamics, Inc.	Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
2023-11-06	Merit Medical Systems, Inc.	The sterility of microcatheter and infusion system devices cannot be guaranteed.
2022-06-30	Micro Therapeutics, Inc.	Outer carton packaging of microcatheters were exposed to wet substance during transport.
2022-06-30	Micro Therapeutics, Inc.	Outer carton packaging of microcatheters were exposed to wet substance during transport.
2020-11-03	Boston Scientific Corporation	This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2017-11-09	Vascular Insights, LLC	Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction

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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.