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.
This recall has been terminated (originally issued April 7, 2016).
- Company
- Vascular Solutions, Inc.
- Recall Initiated
- March 4, 2016
- Posted
- April 7, 2016
- Terminated
- October 19, 2016
- Recall Number
- Z-1275-2016
- Quantity
- 5283
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
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.
Distribution
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
Lot / Code Info
Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286.
Root Cause
Employee error
Action Taken
Consignees were sent on 3/4/2016 via first class mail a Vascular Solutions "Urgent Medical Device Recall" letter dated March 3, 2016. The letter described the problem and the product involved in the recall. It included the "Immediate Action Required of Customer / User" which instructed the customer to identify the product, remove it from inventory, place it in a secure area, and complete and return the VSI Account Inventory Form to the Customer Service Department.