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    

Teleflex IncorporatedJake ElguiczeTreasurer and Vice President, Investor Relations610-948-2836

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