The Recall Desk

Manufacturer

Vascular Solutions, Inc.

17 recalls in our database name Vascular Solutions, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
17
Critical
1
Severe
3
Most recent
2020-10-28

Of the 17 recalls from Vascular Solutions, Inc. we have scored against our rubric, 1 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (18%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

  • HighFDA (Devices)·Z-1747-2020·2020-05-06

    Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

    Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.

    Product
    Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2018·2018-06-27

    Vascular Solutions Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins

    Vascular Solutions, Inc. is recalling specific lots of Drainer Centesis Catheters because the supplier reported a potential for unsafe levels of bacterial endotoxins.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2017·2017-06-28

    Vascular Solutions Recalls Venture Catheters Due to Material Detachment Risk

    Vascular Solutions, Inc. is voluntarily recalling Venture RX, OTW, and CS catheters because material may detach from the distal tip during use.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2017·2017-06-07

    Vascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect

    Vascular Solutions, Inc. is recalling 4,110 Dolphin Inflation Devices due to a potential sterile barrier defect that could lead to microbial contamination and infection.

    Product
    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 compo
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1250-2017·2017-03-01

    Vascular Solutions Recalls GrebSet Micro-Introducer Kits Due to Shelf Life Discrepancy

    Vascular Solutions is recalling 633 units of GrebSet Micro-Introducer Kits because the guidewires have a shorter shelf life than the kit expiration date.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0055-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Dual Access Catheters Due to Manufacturing Residue

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the catheter tip or within the distal rapid exchange lumen.

    Product
    Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 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) cons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass RX Dual Access Catheters Due to Manufacturing Defect

    Vascular Solutions is recalling Twin-Pass RX Dual Access Catheters because excess manufacturing material may remain at the tip or within the distal lumen.

    Product
    Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. 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) consist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Catheters Due to Manufacturing Material

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the tip or in the distal lumen.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1275-2016·2016-04-13

    FDA Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2014·2014-07-09

    Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

    Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner catheter may separate from the hub during use, potentially requiring intervention to prevent injury.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2013·2013-03-27

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions, Inc. is recalling Guardian II and Guardian II NC Hemostasis Valves used in cardiopulmonary bypass because air may be introduced into the device, potentially leading to an air embolism.

    Product
    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 Ze
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0868-2013·2013-02-27

    Vascular Solutions Recalls SuperCross Microcatheters Due to Surface Contamination

    Vascular Solutions, Inc. is recalling SuperCross Microcatheters due to potential surface contamination on aged units discovered during in-house testing.

    Product
    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 di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2012·2012-09-26

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Missing Seals

    Vascular Solutions, Inc. is recalling Guardian II Hemostasis Valves because some pouches are missing a seal, posing a risk of product contamination.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide