Teleflex’s (TFX) Vascular Solutions, Inc. Issues Recall of Venture® Catheters

Vascular Solutions, Inc. voluntarily initiates a worldwide recall of Venture Catheters on April 25, 2017

WAYNE, Pa.--(BUSINESS WIRE)--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 [e-mail].

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 Catheters
Affected 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