Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters
October 04 2016 - 04:05PM
On September 16, 2016, Vascular Solutions, Inc. (Nasdaq:VASC),
initiated a nationwide recall of Twin-Pass Dual Access catheters
used in catheterization procedures. All unexpired lots of the
product have been recalled because there is a potential for excess
manufacturing material to remain at the tip of the catheter or
within the distal portion of the rapid exchange lumen. It is
possible that the excess material may separate from the catheter
during use and pose a potential risk of embolism, which could
result in serious injury or death. No injuries have been
reported in association with this issue to date.
Healthcare facilities that have the affected Twin-Pass dual
access catheters should remove the products from their inventory
and return them to Vascular Solutions.
The recalled products were manufactured from October 2014 to
August 2016 and distributed from October 2014 to September
2016.
The recalled products are all unexpired lots of Model Numbers
5200, 5210, and 5230. A listing of the recalled lots is
available from Vascular Solutions and has been provided to each
facility that purchased the affected products. A total of
15,896 devices have been manufactured, with 5,784 distributed in
the United States and currently unexpired. The condition that
led to the recall may affect approximately 9.2% of recalled
devices.
Vascular Solutions, Inc. voluntarily initiated the recall on
September 16, 2016 through an Urgent Medical Device Recall
notification distributed to purchasers of the affected
products. The notification identified the specific unexpired
lots subject to the recall and included instructions on how to
return the affected products.
The U.S. Food and Drug Administration (FDA) classified this as a
Class I recall. FDA defines Class I recalls as “a situation
in which 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 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
customerservice@vasc.com. Adverse reactions or quality
problems experienced with the use of this product may be reported
to the FDA’s MedWatch Adverse Event Reporting program:
- Online at http://www.fda.gov/medwatch/report.htm (form
available to fax (1-800-FDA-0178) or mail), or
- Call FDA 1-800-FDA-1088 to request a reporting form
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 has launched
more than 100 products that are sold to interventional
cardiologists, interventional radiologists, electrophysiologists,
and vein specialists through its direct U.S. sales force and
international independent distributor network.
For further information, connect to www.vasc.com.
Contact: Phil Nalbone
VP of Corporate Development
Vascular Solutions, Inc. (763) 656-4371
Vascular Solutions, Inc. (NASDAQ:VASC)
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