Food, drugs, devices › Vascular Solutions, Inc.

Device recall: Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers

FDA enforcement event 64511 · Class I · initiated 27 Feb 2013 · status Terminated · terminated 5 Aug 2013

DeviceVoluntary: Firm initiated1 product recordMaple Grove, MN

Vascular Solutions, Inc. (Maple Grove, MN) initiated this device recall on 27 Feb 2013; FDA lists 1 product record under event 64511, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 6% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 5 Aug 2013. Initiation: voluntary: firm initiated. Vascular Solutions, Inc. has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Vascular Solutions, Inc., Maple Grove, MN.

Reason for recall

"Risk that air may be introduced into the device which may lead to an air embolism."

Distribution

"Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0955-2013	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…	79,869	Class I	Terminated	27 Mar 2013

Context

6%of 2013 device events are Class I1,236 events that year

1product record in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for Vascular Solutions, Inc.

Initiated	Product (first record)	Type	Class	Records
31 Aug 2020	Langston Dual Lumen Catheter	Device	Class I	4
16 Mar 2020	Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies	Device	Class I	1
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	Device	Class II	1
25 Apr 2017	Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using eth	Device	Class I	1
12 Apr 2017	Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflati	Device	Class II	1
12 Jan 2017	GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer ki	Device	Class II	1
16 Sep 2016	Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin	Device	Class I	3
4 Mar 2016	Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101	Device	Class I	1
27 May 2014	Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring ca	Device	Class I	1
29 Jan 2013	Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324,	Device	Class II	1

All 12 events for Vascular Solutions, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Risk that air may be introduced into the device which may lead to an air embolism."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Aug 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.