Vascular Solutions, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1275-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.

Product Classification:

Class I

Date Initiated: March 4, 2016

Date Posted: April 13, 2016

Recall Number: Z-1275-2016

Event ID: 73553

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5283

Code Information:

Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286.

Distribution Pattern:

Nationwide Distribution in the states of AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV. OUS: Ireland

Voluntary or Mandated:

Voluntary: Firm initiated