Vascular Solutions, Inc.
FDA Regulatory Profile
Vascular Solutions, Inc. appears in FDA public data with 17 recalls — including 12 Class I (most serious) —, 115 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0111-2021, Class I) was initiated on August 31, 2020. Its most recent 510(k) clearance was granted on May 31, 2024.
Summary
- Total Recalls
- 17 (12 Class I)
- 510(k) Clearances
- 115
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0111-2021 | Class I | Langston Dual Lumen Catheter. | August 31, 2020 |
| Z-0112-2021 | Class I | Langston Dual Lumen Catheter. | August 31, 2020 |
| Z-0110-2021 | Class I | Langston Dual Lumen Catheter | August 31, 2020 |
| Z-0113-2021 | Class I | Langston Dual Lumen Catheter. | August 31, 2020 |
| Z-1747-2020 | Class I | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies | March 16, 2020 |
| Z-2249-2018 | Class II | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 1 | May 4, 2018 |
| Z-2224-2017 | Class I | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. | April 25, 2017 |
| Z-2180-2017 | Class II | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a s | April 12, 2017 |
| Z-1250-2017 | Class II | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The Gr | January 12, 2017 |
| Z-0054-2017 | Class I | Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. | September 16, 2016 |
| Z-0053-2017 | Class I | Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Eth | September 16, 2016 |
| Z-0055-2017 | Class I | Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide | September 16, 2016 |
| Z-1275-2016 | Class I | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside | March 4, 2016 |
| Z-1981-2014 | Class I | Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pr | May 27, 2014 |
| Z-0955-2013 | Class I | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary b | February 27, 2013 |
| Z-0868-2013 | Class II | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model number | January 29, 2013 |
| Z-2400-2012 | Class II | Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intend | August 30, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20m | May 31, 2024 |
| K230637 | Wattson temporary pacing guidewire (2250) | May 5, 2023 |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner | August 18, 2022 |
| K221470 | Langston dual lumen catheter | June 17, 2022 |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLine | February 9, 2022 |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire | February 9, 2022 |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | April 30, 2021 |
| K193119 | Twin-Pass Dual Access Catheter | June 29, 2020 |
| K200720 | D-Stat Radial Topical Hemostat | June 26, 2020 |
| K192454 | Wattson Temporary Pacing Guidewire | January 15, 2020 |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | August 9, 2019 |
| K182570 | Venture 0.014 Catheter | March 13, 2019 |
| K182232 | Octane Mechanical Thrombectomy System | September 11, 2018 |
| K181647 | Bandit guidewire | July 20, 2018 |
| K180913 | VSI Micro-Introducer Kit | May 9, 2018 |
| K180088 | TrapLiner catheter | April 4, 2018 |
| K180128 | Warrior 14 guidewire | February 16, 2018 |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | January 19, 2018 |
| K173532 | Raider Guidewire | December 15, 2017 |
| K173266 | Octane aspiration system | December 1, 2017 |