According to the latest press release from the FDA, Vascular Solutions Inc. one of the renowned names in the manufacturing and marketing of medical device equipments has issued a nationwide, Class I Recall for widely used Guardian II and Guardian II NC homeostasis valves, which are intended to reduce blood loss during catheterization procedures. The move was initiated by the company due to a risk that air may be introduced into the device which may lead to an air embolism. Emboli are air bubble that may interrupt the flow of blood in the heart and can cause serious adverse health consequences, including death.

Though no report of any adverse incidence has come out still the move was initiated by the company as a precautionary measures to avoid any mishap in the future. The was a voluntary one and was initiated after Company’s Quality Assurance team inspected and found some lacunae in the SOP of the team. In its recall notification the company has urged healthcare professional and medical practitioners to remove the affected lots of products from their inventory and return them to Vascular Solutions. The affected lots of products were manufactured from February 2012 to February 2013 and distributed from February 2012 to February 2013.

The recalled products are specific lots of Model Numbers:

  • 8210
  • 8211
  • 8215
  • 8216
  • 8241
  • 8242
  • 8244
  • 8272
  • 8274

A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products.

Consumers with queries and questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA online or may also call FDA at 1-800-FDA-1088

About Vascular Solutions:

Vascular Solutions, Inc. is a U.S. based medical devices company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of over 60 products in three categories: hemostat products, catheter products, and vein products. Radiologists and Cardiologists worldwide rely on the quality and clinical effectiveness of products that are manufactured and marketed by Vascular Solutions.