Teleflex Incorporated Announces Worldwide Recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX) announces worldwide recall of ARROW®
International Intra-Aortic Balloon Catheter Kits and Percutaneous
Insertion Kits. The Arrow® IAB is inserted in the aorta and
provides mechanical circulatory support for cardiac patients, by
inflating and deflating at different phases of the cardiac cycle to
increase cardiac output and decrease the work of the heart.

Teleflex Incorporated announced today that the U.S. Food and Drug
Administration (FDA) has classified the recall of ARROW®
International Intra-Aortic Balloon Catheter Kits and Percutaneous
Insertion Kits as a Class I recall. FDA defines a 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.”

On 9-Feb-2016, Teleflex Incorporated initiated a worldwide recall of
47,140 units distributed to hospitals, clinics, and medical centers
throughout the United States and globally. The ARROW®
International Intra-Aortic Balloon Catheter Kits and Percutaneous
Insertion Kits are being recalled because the sheath body may become
separated from the sheath hub. If the separation occurs, the patient may
bleed from the sheath. If bleeding is not promptly addressed,
significant blood loss or exsanguination may occur. Interruption or loss
of intra-aortic balloon pump treatment may also occur. At the time of
the recall, there were 13 adverse events reported; including 6 serious
injuries and 1 death.

Teleflex notified domestic distributors and customers via an Urgent
Medical Device recall letter dated February 11, 2016. Consumers who have
affected product should immediately discontinue use and return all
affected product to Teleflex.

Teleflex 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
  IAB-05830-LWS       Reference Appendix
  IAB-05830-U
  IAB-05840-LWS
  IAB-05840-U
  IAB-06830-U
  IAB-06840-U
  IAB-S730C
  IAK-06845
  IAK-S7IT      
 

The original recall notice can be found at Teleflex’s website: http://www.teleflex.com/en/recall/Customer_letter_and_form_press_release.pdf

Consumers with questions may contact the company at 1-866-246-6990; 8am
to 8pm, ET, Monday through Friday or at recalls@teleflex.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.

     
Product Code   Lot
IAB-05830-LWS   18F14A0031
IAB-05830-LWS   18F14A0032
IAB-05830-LWS   18F14A0033
IAB-05830-LWS   18F14D0066
IAB-05830-LWS   18F14E0018
IAB-05830-LWS   18F14E0072
IAB-05830-LWS   18F14F0067
IAB-05830-LWS   18F14F0079
IAB-05830-LWS   18F14G0045
IAB-05830-LWS   18F14G0046
IAB-05830-LWS   18F14G0081
IAB-05830-LWS   18F14H0037
IAB-05830-LWS   18F14J0023
IAB-05830-LWS   18F14L0014
IAB-05830-LWS   18F14M0033
IAB-05830-LWS   18F15A0010
IAB-05830-LWS   18F15B0015
IAB-05830-LWS   18F15C0004
IAB-05830-LWS   18F15C0023
IAB-05830-LWS   18F15D0025
IAB-05830-LWS   18F15D0052
IAB-05830-LWS   18F15E0020
IAB-05830-LWS   18F15F0002
IAB-05830-LWS   18F15F0039
IAB-05830-LWS   18F15G0005
IAB-05830-LWS   18F15G0015
IAB-05830-LWS   18F15H0006
IAB-05830-LWS   18F15H0037
IAB-05830-LWS   18F15H0051
IAB-05830-LWS   18F15J0026
IAB-05830-LWS   18F15L0007
IAB-05830-LWS   18S14G0046
IAB-05830-LWS   18S15A0021
IAB-05830-U   18F14E0030
IAB-05830-U   18F14H0019
IAB-05830-U   18F14J0038
IAB-05830-U   18F14K0012
IAB-05830-U   18F14K0019
IAB-05830-U   18F15D0030
IAB-05830-U   18F15E0017
IAB-05840-LWS   18F14A0025
IAB-05840-LWS   18F14A0026
IAB-05840-LWS   18F14A0030
IAB-05840-LWS   18F14A0049
IAB-05840-LWS   18F14A0050
IAB-05840-LWS   18F14A0051
IAB-05840-LWS   18F14A0054
IAB-05840-LWS   18F14A0057
IAB-05840-LWS   18F14A0066
IAB-05840-LWS   18F14A0067
IAB-05840-LWS   18F14D0045
IAB-05840-LWS   18F14E0004
IAB-05840-LWS   18F14E0006
IAB-05840-LWS   18F14E0016
IAB-05840-LWS   18F14E0017
IAB-05840-LWS   18F14E0052
IAB-05840-LWS   18F14F0017
IAB-05840-LWS   18F14F0047
IAB-05840-LWS   18F14F0049
IAB-05840-LWS   18F14F0080
IAB-05840-LWS   18F14G0003
IAB-05840-LWS   18F14G0004
IAB-05840-LWS   18F14G0021
IAB-05840-LWS   18F14G0037
IAB-05840-LWS   18F14G0055
IAB-05840-LWS   18F14G0056
IAB-05840-LWS   18F14G0068
IAB-05840-LWS   18F14G0070
IAB-05840-LWS   18F14G0071
IAB-05840-LWS   18F14G0076
IAB-05840-LWS   18F14H0009
IAB-05840-LWS   18F14H0030
IAB-05840-LWS   18F14H0054
IAB-05840-LWS   18F14H0055
IAB-05840-LWS   18F14H0060
IAB-05840-LWS   18F14H0061
IAB-05840-LWS   18F14J0003
IAB-05840-LWS   18F14J0005
IAB-05840-LWS   18F14J0037
IAB-05840-LWS   18F14K0006
IAB-05840-LWS   18F14M0001
IAB-05840-LWS   18F14M0014
IAB-05840-LWS   18F14M0032
IAB-05840-LWS   18F15A0005
IAB-05840-LWS   18F15A0011
IAB-05840-LWS   18F15A0026
IAB-05840-LWS   18F15A0034
IAB-05840-LWS   18F15B0005
IAB-05840-LWS   18F15B0008
IAB-05840-LWS   18F15B0010
IAB-05840-LWS   18F15B0018
IAB-05840-LWS   18F15B0020
IAB-05840-LWS   18F15B0027
IAB-05840-LWS   18F15C0002
IAB-05840-LWS   18F15C0007
IAB-05840-LWS   18F15C0010
IAB-05840-LWS   18F15C0015
IAB-05840-LWS   18F15C0024
IAB-05840-LWS   18F15C0030
IAB-05840-LWS   18F15C0036
IAB-05840-LWS   18F15D0017
IAB-05840-LWS   18F15D0032
IAB-05840-LWS   18F15D0034
IAB-05840-LWS   18F15D0043
IAB-05840-LWS   18F15D0049
IAB-05840-LWS   18F15E0003
IAB-05840-LWS   18F15E0011
IAB-05840-LWS   18F15E0014
IAB-05840-LWS   18F15E0023
IAB-05840-LWS   18F15E0029
IAB-05840-LWS   18F15E0037
IAB-05840-LWS   18F15F0011
IAB-05840-LWS   18F15F0017
IAB-05840-LWS   18F15F0021
IAB-05840-LWS   18F15F0032
IAB-05840-LWS   18F15G0001
IAB-05840-LWS   18F15G0013
IAB-05840-LWS   18F15G0021
IAB-05840-LWS   18F15G0028
IAB-05840-LWS   18F15G0034
IAB-05840-LWS   18F15H0010
IAB-05840-LWS   18F15H0015
IAB-05840-LWS   18F15H0021
IAB-05840-LWS   18F15H0024
IAB-05840-LWS   18F15H0033
IAB-05840-LWS   18F15J0013
IAB-05840-LWS   18F15J0028
IAB-05840-LWS   18F15J0038
IAB-05840-LWS   18F15J0044
IAB-05840-LWS   18F15J0049
IAB-05840-LWS   18F15K0001
IAB-05840-LWS   18F15K0007
IAB-05840-LWS   18F15L0002
IAB-05840-LWS   18S14G0068
IAB-05840-LWS   18S14M0001
IAB-05840-LWS   18S15C0002
IAB-05840-U   18F14B0044
IAB-05840-U   18F14B0045
IAB-05840-U   18F14E0060
IAB-05840-U   18F14F0019
IAB-05840-U   18F14G0067
IAB-05840-U   18F14H0002
IAB-05840-U   18F14J0026
IAB-05840-U   18F15A0033
IAB-05840-U   18F15B0009
IAB-05840-U   18F15B0019
IAB-05840-U   18F15C0012
IAB-05840-U   18F15D0016
IAB-05840-U   18F15D0037
IAB-05840-U   18F15D0044
IAB-05840-U   18F15F0001
IAB-06830-U   18F13M0016
IAB-06830-U   18F14A0017
IAB-06830-U   18F14A0018
IAB-06830-U   18F14A0022
IAB-06830-U   18F14A0046
IAB-06830-U   18F14E0054
IAB-06830-U   18F14E0070
IAB-06830-U   18F14G0038
IAB-06830-U   18F14G0078
IAB-06830-U   18F14H0007
IAB-06830-U   18F14J0007
IAB-06830-U   18F14J0025
IAB-06830-U   18F14K0016
IAB-06830-U   18F15A0035
IAB-06830-U   18F15B0006
IAB-06830-U   18F15B0014
IAB-06830-U   18F15C0019
IAB-06830-U   18F15E0028
IAB-06830-U   18F15F0016
IAB-06830-U   18F15G0007
IAB-06830-U   18F15H0009
IAB-06830-U   18F15H0035
IAB-06840-U   18F13M0017
IAB-06840-U   18F13M0019
IAB-06840-U   18F13M0021
IAB-06840-U   18F14A0012
IAB-06840-U   18F14A0013
IAB-06840-U   18F14A0015
IAB-06840-U   18F14A0016
IAB-06840-U   18F14A0044
IAB-06840-U   18F14A0047
IAB-06840-U   18F14B0042
IAB-06840-U   18F14B0043
IAB-06840-U   18F14D0068
IAB-06840-U   18F14E0005
IAB-06840-U   18F14E0007
IAB-06840-U   18F14E0031
IAB-06840-U   18F14E0053
IAB-06840-U   18F14E0069
IAB-06840-U   18F14F0030
IAB-06840-U   18F14F0031
IAB-06840-U   18F14F0066
IAB-06840-U   18F14G0020
IAB-06840-U   18F14G0039
IAB-06840-U   18F14G0066
IAB-06840-U   18F14H0003
IAB-06840-U   18F14H0010
IAB-06840-U   18F14H0023
IAB-06840-U   18F14H0024
IAB-06840-U   18F14H0056
IAB-06840-U   18F14J0006
IAB-06840-U   18F14J0016
IAB-06840-U   18F14J0027
IAB-06840-U   18F14J0051
IAB-06840-U   18F15A0008
IAB-06840-U   18F15A0015
IAB-06840-U   18F15A0023
IAB-06840-U   18F15B0003
IAB-06840-U   18F15B0007
IAB-06840-U   18F15B0021
IAB-06840-U   18F15C0006
IAB-06840-U   18F15C0011
IAB-06840-U   18F15C0027
IAB-06840-U   18F15D0010
IAB-06840-U   18F15D0019
IAB-06840-U   18F15D0045
IAB-06840-U   18F15E0002
IAB-06840-U   18F15E0012
IAB-06840-U   18F15F0008
IAB-06840-U   18F15F0028
IAB-06840-U   18F15F0038
IAB-06840-U   18F15F0041
IAB-06840-U   18F15G0016
IAB-06840-U   18F15G0027
IAB-06840-U   18F15H0005
IAB-06840-U   18F15H0020
IAB-06840-U   18F15H0032
IAB-06840-U   18F15H0041
IAB-06840-U   18F15J0007
IAB-06840-U   18F15J0010
IAB-06840-U   18F15J0021
IAB-06840-U   18F15J0029
IAB-06840-U   18F15J0039
IAB-06840-U   18F15J0056
IAB-06840-U   18F15K0016
IAB-06840-U   18F15K0032
IAB-06840-U   18F15L0001
IAB-06840-U   18F15L0010
IAB-S730C   18F14A0041
IAB-S730C   18F14C0003
IAB-S730C   18F14C0006
IAB-S730C   18F14C0021
IAB-S730C   18F14C0026
IAB-S730C   18F14C0027
IAB-S730C   18F14C0028
IAB-S730C   18F14E0039
IAB-S730C   18F14E0055
IAB-S730C   18F14E0058
IAB-S730C   18F14F0035
IAB-S730C   18F14F0038
IAB-S730C   18F14F0054
IAB-S730C   18F14G0057
IAB-S730C   18F14G0077
IAB-S730C   18F14H0011
IAB-S730C   18F15B0023
IAB-S730C   18F15C0001
IAB-S730C   18F15C0008
IAB-S730C   18F15C0026
IAB-S730C   18F15D0028
IAB-S730C   18F15F0027
IAB-S730C   18F15F0037
IAB-S730C   18F15G0003
IAB-S730C   18F15G0011
IAB-S730C   18F15G0032
IAB-S730C   18F15H0046
IAB-S730C   18F15M0009
IAK-06845   18F14A0037
IAK-06845   18F14B0040
IAK-06845   18F14E0027
IAK-06845   18F14F0027
IAK-06845   18F14F0028
IAK-S7IT   18F14A0028
IAK-S7IT   18F14B0008
IAK-S7IT   18F14D0003

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.

Contacts

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice
President, Investor Relations
610-948-2836