Vascular Solutions, Inc. Issues Recall of Langston(R) Dual Lumen Catheters
July 03 2014 - 4:05PM
On May 23, 2014, Vascular Solutions, Inc. (Nasdaq:VASC) initiated a
voluntary nationwide recall of Langston dual lumen catheters used
in catheterization procedures. The Langston dual lumen catheter is
indicated for delivery of contrast medium in angiographic studies
and for simultaneous pressure measurement from two sites. This type
of pressure measurement is useful in determining transvalvular,
intravascular, and intraventricular pressure gradients. Specific
lots of the products have been recalled because of the potential
for the inner catheter to separate from the hub during use and
travel into the patient's circulation. This may require an
intervention or surgery to retrieve the separated piece. In
addition, the operator may be at increased risk of contact with
contrast or bodily fluid, which could potentially result in
infection or injury to the operator.
To date, there have been two reports of the inner catheter
entering the patient's ventricle, requiring retrieval. No injuries
have been reported.
Healthcare facilities that have the affected Langston dual lumen
catheters should remove the products from their inventory and
return them to Vascular Solutions. A list of recalled lots is
available from Vascular Solutions and has been provided to each
facility that purchased the affected products. The specific
affected lots of Langston were of Model Numbers 5540 and 5550, were
manufactured from January 2014 to April 2014, and distributed from
March 2014 to May 2014. A total of 8,580 of the catheters subject
to the recall were sold, with approximately 3,847 still unused in
the field.
Vascular Solutions initiated the voluntary recall and notified
its affected customers by letter, following-up by phone call and
in-person visit as necessary to ensure the return of all available
affected products. To date, over 86% of inventory has been
accounted for and product is being returned to the company. The
notification included instructions on how to return the affected
products.
The U.S. Food and Drug Administration (FDA) classified this as a
Class 1 recall. FDA defines Class 1 recalls as, "a situation where
there is a reasonable probability that the use of, or exposure to,
a violative product will cause serious adverse health consequences
or death."
Consumers with questions may contact Vascular Solutions 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
customerservice@vasc.com. Adverse reactions or quality
problems experienced with the use of this product may be reported
to the FDA:
- Online at
http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or
- Call FDA 1-800-FDA-1088
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company
that focuses on developing unique clinical solutions for coronary
and peripheral vascular procedures. The company's product line
consists of more than 80 products in three categories: catheter
products, hemostat products, and vein products. Vascular
Solutions delivers its products to interventional cardiologists,
interventional radiologists, electrophysiologists and vein
specialists through its direct U.S. sales force and international
independent distributor network.
For further information, visit www.vasc.com.
CONTACT: Howard Root
Chief Executive Officer
Vascular Solutions, Inc.
(763) 656-4300
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