RegWardenFDA facility compliance records
Company

Vascular Solutions LLC

12 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 2 recalls; 2014: 1 recalls; 2016: 2 recalls; 2017: 3 recalls; 2018: 1 recalls; 2020: 2 recalls1’122’131’14’152’163’171’18’192’20’21’22’23’24’25’26
  • Recalls (12)

Registered facilities (2)

Recalls & enforcement

  • Class ITerminated2020-08-31
    The inner lumen of the Langston catheter may separate from the hub during pressure injection.
  • Class ITerminated2020-03-16
    The inner lumen of the Langston catheter may separate from the hub during pressure injection.
  • Class IITerminated2018-05-04
    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.
  • Class ITerminated2017-04-25
    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 cathet…
  • Class IITerminated2017-04-12
    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.
  • Class IITerminated2017-01-12
    Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
  • Class ITerminated2016-09-16
    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.
  • Class ITerminated2016-03-04
    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.
  • Class ITerminated2014-05-27
    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.
  • Class ITerminated2013-02-27
    Risk that air may be introduced into the device which may lead to an air embolism.
  • Class IITerminated2013-01-29
    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.
  • Class IITerminated2012-08-30
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Vascular Solutions LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9029941-vascular-solutions-llc/

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