Teleflex’s (TFX) Vascular Solutions, Inc. Issues Recall of Venture® Catheters
June 22 2017 - 5:00PM
Business Wire
Vascular Solutions, Inc. voluntarily initiates
a worldwide recall of Venture Catheters on April 25, 2017
Teleflex Incorporated (NYSE: TFX), announces a worldwide recall
of Venture® Catheters was voluntarily initiated by its Vascular
Solutions, Inc. subsidiary on April 25, 2017. Vascular Solutions,
Inc. is the manufacturer of Venture Catheters, which are designed
for use in catheterization procedures, to direct, steer, control,
and support a guidewire to access discrete regions of the coronary
and peripheral vasculature. Two versions may also be used for
manual delivery of saline solution or diagnostic contrast
agents.
The U.S. Food and Drug Administration (FDA) classified this as a
Class I recall. The FDA defines Class I recall 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."
The worldwide recall affects 4,679 units distributed in the
United States. All unexpired lots of the Rapid Exchange (RX),
Over-the-Wire (OTW), and Coronary Sinus (CS) versions of the
product have been recalled due to the potential for excess material
to be present within the inner lumen of the distal catheter tip. 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. No serious injuries or death have been
reported in association with this issue to date.
Vascular Solutions, Inc. initiated the recall through an Urgent
Medical Device Recall notification distributed to purchasers of the
affected products. Healthcare facilities with affected Venture
Catheters should remove the products from their inventory and
return them to Vascular Solutions, Inc. The notification identified
the specific unexpired lots subject to the recall and included
instructions on how to return the affected products to Vascular
Solutions, Inc.
Vascular Solutions, Inc. has notified the FDA of this
action.
See table below for affected product codes. A full list of
affected lot numbers can be found in the appendix to this
notification.
PRODUCTS AFFECTED
Product Code
Lot 5820
Refer to appendix for all line items
5821 5822
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 either online, by regular mail or by fax:
- Complete and submit the
report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download
form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax
to 1-800-FDA-0178.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed
to improve the health and quality of people’s lives. We apply
purpose driven innovation – a relentless pursuit of identifying
unmet clinical needs – to benefit patients and healthcare
providers. Our portfolio is diverse, with solutions in the fields
of vascular and interventional access, surgical, anesthesia,
cardiac care, urology, emergency medicine and respiratory care.
Teleflex employees worldwide are united in the understanding that
what we do every day makes a difference. For more information,
please visit teleflex.com
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®,
Pilling®, Rusch®, and Weck® – trusted brands united by a common
sense of purpose.
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking
statements. Any forward-looking statements contained herein are
based on our management's current beliefs and expectations, but are
subject to a number of risks, uncertainties, and changes in
circumstances, which may cause actual results or company actions to
differ materially from what is expressed or implied by these
statements. These risks and uncertainties are identified and
described in more detail in our filings with the Securities and
Exchange Commission, including our Annual Report on Form 10-K.
Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA,
Pilling, Rusch, Venture, and Weck are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.
© 2017 Teleflex Incorporated. All rights reserved.
Vascular Solutions, Inc. Venture
CathetersAffected Product Codes and Lots
Product
Code Lot 5820
582455 5820 582588
5820 583022 5820
583409 5820
584469 5820 584470
5820 585180 5820
585458 5820 585787
5820 587035 5820
587036 5820 587775
5820 588097 5820
588098 5820
588794 5820 589885
5820 589886 5820
590172 5820 590776
5820 591196 5820
591198 5820 592080
5820 592526 5820
593080 5820
593519 5820 593720
5820 594204 5820
594421 5820 595195
5820 595418 5820
597293 5820 597771
5820 597967 5820
598903 5820
599045 5820 599466
5820 599903 5820
601745 5820 603987
5820 603988 5820
603991 5820 604500
5821 581713 5821
583410 5821
584471 5821 585459
5821 586408 5821
586972 5821 587408
5821 588099 5821
589268 5821 589754
5821 590404 5821
591197 5821
592081 5821 592924
5821 593520 5821
595196 5821 595419
5821 596020 5821
597294 5821 599650
5821 601196 5821
601746 5821
602260 5821 603990
5821 604049 5821
605617 5822 588100
5822 590562 5822
597905 5822 599777
5822 604862
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Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
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