Vascular Solutions, Inc.

FDA recalling firm · 12 enforcement events · 17 product records · 2012–2020 · MN

Vascular Solutions, Inc. has 12 FDA enforcement events on this register (17 product records) between 2012 and 2020: 12 device; the busiest year was 2017 with 3.

58% of its events are Class I; the most common class is Class I (7). 0 events are listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
31 Aug 2020	Langston Dual Lumen Catheter	Device	Class I	4	Terminated
16 Mar 2020	Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies	Device	Class I	1	Terminated
4 May 2018	Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.	Device	Class II	1	Terminated
25 Apr 2017	Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The…	Device	Class I	1	Terminated
12 Apr 2017	Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume…	Device	Class II	1	Terminated
12 Jan 2017	GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.	Device	Class II	1	Terminated
16 Sep 2016	Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW)…	Device	Class I	3	Terminated
4 Mar 2016	Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human…	Device	Class I	1	Terminated
27 May 2014	Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.	Device	Class I	1	Terminated
27 Feb 2013	Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis…	Device	Class I	1	Terminated
29 Jan 2013	Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or…	Device	Class II	1	Terminated
30 Aug 2012	Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105")…	Device	Class II	1	Terminated

By type and class

Device12

Class I7

Class II5

Class I: 58% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Vascular Solutions, Inc. by year initiated.

Questions and answers

How many FDA recalls has Vascular Solutions, Inc. had?

12 enforcement events (17 product records) on this register, 2012–2020: 12 device.

Are any Vascular Solutions, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Vascular Solutions, Inc. recalls?

7 Class I, 5 Class II. 58% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.