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Vascular Solutions, Inc.

United States·US-MF-000027428

Last updated May 24, 2026

What Vascular Solutions, Inc. makes

Vascular Solutions, Inc. manufactures medical devices for vascular access, embolization, and minimally invasive vein treatments, including laser fiber kits for varicose vein procedures, nonimplantable vascular catheters, guidewires, and hemostatic agents. Their portfolio also includes single-use vascular guide catheters, non-neurovascular embolization plugs derived from animal sources, and ultrasound systems for noninvasive vascular imaging. Additional products encompass infusion catheters for peripheral vascular interventions and manual guidewires designed for vascular procedures.

The company’s devices are regulated under various classifications, including FDA Class II, Class III, Class IIa, and Class U, with some listed in the EU’s eudamed registry and authorised via FDA pathways such as 510(k), PMA, and UDI submissions. The manufacturer operates from the United States, ensuring compliance with domestic and international regulatory standards for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Vascular Solutions, Inc. manufacture?

Vascular Solutions, Inc. specializes in devices for vascular and vein treatments, including kits for varicose vein laser procedures, nonimplantable vascular catheters, guidewires, and hemostatic agents. Their portfolio also covers single-use vascular guide catheters, non-neurovascular embolization plugs (derived from animal sources), and noninvasive vascular ultrasound systems. These products are designed for vascular access, embolization, and minimally invasive interventions.

Where is Vascular Solutions, Inc. based, and how does this affect its regulatory compliance?

Vascular Solutions, Inc. is based in the United States, which means its devices must comply with both domestic (FDA) and international regulatory standards. The company’s products are authorised through FDA pathways like 510(k), PMA, and UDI submissions, ensuring adherence to U.S. medical device regulations. Their U.S. location also influences their participation in global registries like eudamed for EU market access.

Which regulatory registries list devices manufactured by Vascular Solutions, Inc.?

Devices from Vascular Solutions, Inc. are listed in multiple regulatory databases, including the EU’s eudamed registry for transparency in the European market. In the U.S., their devices are authorised via FDA pathways such as 510(k) clearances, PMA approvals, and UDI submissions, ensuring traceability and compliance. These registries help healthcare providers and regulators verify device authorisation status.

How are Vascular Solutions, Inc.’s devices classified under medical device regulations?

Vascular Solutions, Inc.’s devices fall under various regulatory classifications depending on their risk level and intended use. For example, some products like vascular catheters and guidewires are classified as FDA Class II or Class IIa, requiring special controls to ensure safety and effectiveness. Higher-risk devices, such as embolization plugs or certain laser systems, may be classified as Class III, necessitating rigorous premarket approval (PMA) processes. Class U devices are unclassified but still subject to regulatory oversight.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 6464, Sycamore Court North, Minneapolis, United States
Website: teleflex.com/emea/contact/europe-middle-east-africa/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 353 (0) 9 06 46 08 00
PRRC Contact: Julie Underdahl
EUDAMED SRN: US-MF-000027428
FDA FEI Number: —
DUNS Number: 008999906

Catalogue (503)

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Device	Model / Reference	Registries	Class	Status
VSI Radial™ introducer sheath	8988	FDA UDI	Class II	Active
VSI Micro-Introducer Kit	7255V	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7208X	FDA UDI	Class II	Active
Quattro Elite™ snare	8411	FDA UDI	Class II	Unknown
Turnpike® Gold catheter	5621	FDA UDI	Class II	Unknown
Pronto® V4 extraction catheter	4008	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7195V	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	9217V	FDA UDI	Class II	Unknown
Minnie® support catheter	5712	FDA UDI	Class II	Active
GuideLiner® Navigation™ catheter	5472	FDA UDI	Class II	Unknown
VSI Tru-Torque™ guidewire	7471	FDA UDI	Class II	Unknown
R350™ guidewire	7390	FDA UDI	Class II	Active
Vari-Lase® Platinum Bright Tip laser fiber and procedure kits	7159	FDA UDI	Class II	Active
VSI Radial™ introducer sheath	9011	FDA UDI	Class II	Unknown
Warrior™ guidewire	7389	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7270V	FDA UDI	Class II	Unknown
VSI Basic Radiofrequency Ablation Procedure Pack with 7F 7cm Introducer Kit	7786	FDA UDI	Class I	Unknown
VSI Micro-Introducer Kit	7280V	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7206V	FDA UDI	Class II	Unknown
SmartNeedle® vascular access system	78060	FDA UDI	Class II	Active
Gel-Block™ 10x Embolization Pledgets	3642	FDA UDI	Class II	Unknown
VSI Guidewire	7343	FDA UDI	Class II	Active
Axis™ guidewire	7370	FDA UDI	Class II	Unknown
Gandras® VISCI-G catheter	5585	FDA UDI	Class II	Unknown
Quattro Elite™ snare	8412	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7207V	FDA UDI	Class II	Unknown
VSI Radial™ introducer sheath	8998	FDA UDI	Class II	Unknown
ThrombiDisc™ topical hemostat	4150	FDA UDI	U	Unknown
Thrombix® Hemostasis Patch topical hemostat	3101	FDA UDI	U	Active
Vari-Lase® Flex laser fiber and procedure kits	7162	FDA UDI	Class II	Active
Fluent™ inflation device	8251	FDA UDI	Class II	Unknown
Sympro Elite™ snare	8420	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7256X	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7254V	FDA UDI	Class II	Unknown
SmartNeedle® vascular access system	67503	FDA UDI	Class II	Unknown
VSI .025" Guidewire	7385	FDA UDI	Class II	Unknown
VSI Radial™ introducer sheath	8987	FDA UDI	Class II	Active
VSI Guidewire	7300	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7273V	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7194V	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	9219V	FDA UDI	Class II	Unknown
VSI StraitSet™ micro-introducer kit	7961	FDA UDI	Class II	Active
Micro Elite™ snare	8302	FDA UDI	Class II	Unknown
VSI Micro-Introducer Kit	7265V	FDA UDI	Class II	Unknown
GrebSet® micro-introducer kit	7950	FDA UDI	Class II	Unknown
VSI Radial™ introducer sheath	8990	FDA UDI	Class II	Active
VSI StraitSet™ micro-introducer kit	7960	FDA UDI	Class II	Active
VSI Radial™ introducer sheath	9002	FDA UDI	Class II	Unknown
Gel-Block™ Embolization Pledgets	3632	FDA UDI	Class II	Unknown
Pronto® XL extraction catheter	5090	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

Teleflex Medical IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (29)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 31, 2020	Z-0110-2021	—	terminated	The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Aug 31, 2020	Z-0111-2021	—	terminated	The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Aug 31, 2020	Z-0112-2021	—	terminated	The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Aug 31, 2020	Z-0113-2021	—	terminated	The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Mar 16, 2020	Z-1747-2020	—	terminated	The inner lumen of the Langston catheter may separate from the hub during pressure injection.
May 4, 2018	Z-2249-2018	—	terminated	The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
Apr 25, 2017	Z-2224-2017	—	terminated	Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.
Apr 12, 2017	Z-2180-2017	—	terminated	The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection.
Jan 12, 2017	Z-1250-2017	—	terminated	Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
Sep 16, 2016	Z-0054-2017	—	terminated	Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
Sep 16, 2016	Z-0053-2017	—	terminated	Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
Sep 16, 2016	Z-0055-2017	—	terminated	Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
Mar 4, 2016	Z-1275-2016	—	terminated	Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
May 27, 2014	Z-1981-2014	—	terminated	The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
Feb 27, 2013	Z-0955-2013	—	terminated	Risk that air may be introduced into the device which may lead to an air embolism.
Jan 29, 2013	Z-0868-2013	—	terminated	Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
Aug 30, 2012	Z-2400-2012	—	terminated	Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
Jan 17, 2012	Z-1655-2012	—	terminated	Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention.
Jul 11, 2011	Z-2946-2011	—	terminated	Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This may cause injury and/or procedural delay, resulting in a deteriorating hemodynamic condition of the patient which may require medical intervention.
Jun 9, 2011	Z-2770-2011	—	terminated	Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal, posing a risk of product contamination. It is possible that a compromised sterile barrier
Jan 10, 2011	Z-1521-2011	—	terminated	Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896. Recently it was reported that the endovenous laser fiber cage and guidewire tip of the WireFiber became separated. It is possible that separation could occur during patient procedure and has the p
Sep 2, 2010	Z-2608-2010	—	terminated	Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk of product contamination. It is possib
Nov 20, 2009	Z-0547-2010	—	terminated	It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and was realized to have an expiration date of October 31, 2009.
Jul 2, 2009	Z-1712-2009	—	terminated	Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging
Sep 9, 2005	Z-0143-06	—	terminated	A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.
Sep 9, 2005	Z-0142-06	—	terminated	A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.
Sep 9, 2005	Z-0144-06	—	terminated	A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.
May 12, 2004	Z-1089-04	—	terminated	The marker band in guidewire lumen could move from the manufactured location during clinical use.
Oct 9, 2003	Z-0101-04	—	terminated	An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement.