Vascular Solutions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
17 (12 Class I)
510(k) Clearances
115
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0112-2021Class ILangston Dual Lumen Catheter.August 31, 2020
Z-0110-2021Class ILangston Dual Lumen CatheterAugust 31, 2020
Z-0111-2021Class ILangston Dual Lumen Catheter.August 31, 2020
Z-0113-2021Class ILangston Dual Lumen Catheter.August 31, 2020
Z-1747-2020Class ILangston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studiesMarch 16, 2020
Z-2249-2018Class IIDrainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 1May 4, 2018
Z-2224-2017Class IVenture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. April 25, 2017
Z-2180-2017Class IIDolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a sApril 12, 2017
Z-1250-2017Class IIGrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrJanuary 12, 2017
Z-0054-2017Class IVascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. September 16, 2016
Z-0055-2017Class IVascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene OxideSeptember 16, 2016
Z-0053-2017Class IVascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with EthSeptember 16, 2016
Z-1275-2016Class IGuardian II Hemostasis Valve, models 8210 and 8211. The following models are only available OutsideMarch 4, 2016
Z-1981-2014Class ILangston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen PrMay 27, 2014
Z-0955-2013Class IVascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bFebruary 27, 2013
Z-0868-2013Class IIVascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numberJanuary 29, 2013
Z-2400-2012Class IIGuardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. IntendAugust 30, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mMay 31, 2024
K230637Wattson temporary pacing guidewire (2250)May 5, 2023
K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner August 18, 2022
K221470Langston dual lumen catheterJune 17, 2022
K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLineFebruary 9, 2022
K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireFebruary 9, 2022
K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterApril 30, 2021
K193119Twin-Pass Dual Access CatheterJune 29, 2020
K200720D-Stat Radial Topical HemostatJune 26, 2020
K192454Wattson Temporary Pacing GuidewireJanuary 15, 2020
K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterAugust 9, 2019
K182570Venture 0.014 CatheterMarch 13, 2019
K182232Octane Mechanical Thrombectomy SystemSeptember 11, 2018
K181647Bandit guidewireJuly 20, 2018
K180913VSI Micro-Introducer KitMay 9, 2018
K180088TrapLiner catheterApril 4, 2018
K180128Warrior 14 guidewireFebruary 16, 2018
K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volumeJanuary 19, 2018
K173532Raider GuidewireDecember 15, 2017
K173266Octane aspiration systemDecember 1, 2017