Vascular Solutions, Inc.
Complete recall history across all FDA and CPSC categories — 17 total recalls
Vascular Solutions, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (17)
FDA medical device enforcement actions by Vascular Solutions, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 31, 2020 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pre... | Class I |
| Aug 31, 2020 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pre... | Class I |
| Aug 31, 2020 | Langston Dual Lumen Catheter | The inner lumen of the Langston catheter may separate from the hub during pre... | Class I |
| Aug 31, 2020 | Langston Dual Lumen Catheter. | The inner lumen of the Langston catheter may separate from the hub during pre... | Class I |
| Mar 16, 2020 | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium ... | The inner lumen of the Langston catheter may separate from the hub during pre... | Class I |
| May 4, 2018 | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9c... | The supplier of Drainer(R) centesis catheters notified Vascular Solutions, In... | Class II |
| Apr 25, 2017 | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS... | Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture ca... | Class I |
| Apr 12, 2017 | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxi... | The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initia... | Class II |
| Jan 12, 2017 | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. ... | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires th... | Class II |
| Sep 16, 2016 | Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 523... | Vascular Solutions is recalling Twin-Pass dual access catheters because ther... | Class I |
| Sep 16, 2016 | Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized... | Vascular Solutions is recalling Twin-Pass dual access catheters because ther... | Class I |
| Sep 16, 2016 | Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterili... | Vascular Solutions is recalling Twin-Pass dual access catheters because ther... | Class I |
| Mar 4, 2016 | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are... | Vascular Solutions became aware of a potential problem with the click version... | Class I |
| May 27, 2014 | Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions... | The inner catheter of some Langston V2 Dual Lumen Catheters have separated fr... | Class I |
| Feb 27, 2013 | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, us... | Risk that air may be introduced into the device which may lead to an air embo... | Class I |
| Jan 29, 2013 | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide... | Vascular Solutions, Inc has discovered a potential problem with a number of l... | Class II |
| Aug 30, 2012 | Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve,... | Vascular Solutions, Inc., became aware of a potential problem involving pouch... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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