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COMPANY ANNOUNCEMENT

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

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

Summary

Company Announcement Date:
March 11, 2016
FDA Publish Date:
November 03, 2018
Reason for Announcement:
Company Name:
Teleflex Incorporated
Brand Name:
Brand Name(s)
Arrow
Product Description:
Product Description
Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

Company Announcement

WAYNE, Pa. – 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 CodeLot
IAB-05830-LWSReference 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.

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.


ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

Affected Product Codes and Lots

Product CodeLot
IAB-05830-LWS18F14A0031
IAB-05830-LWS18F14A0032
IAB-05830-LWS18F14A0033
IAB-05830-LWS18F14D0066
IAB-05830-LWS18F14E0018
IAB-05830-LWS18F14E0072
IAB-05830-LWS18F14F0067
IAB-05830-LWS18F14F0079
IAB-05830-LWS18F14G0045
IAB-05830-LWS18F14G0046
IAB-05830-LWS18F14G0081
IAB-05830-LWS18F14H0037
IAB-05830-LWS18F14J0023
IAB-05830-LWS18F14L0014
IAB-05830-LWS18F14M0033
IAB-05830-LWS18F15A0010
IAB-05830-LWS18F15B0015
IAB-05830-LWS18F15C0004
IAB-05830-LWS18F15C0023
IAB-05830-LWS18F15D0025
IAB-05830-LWS18F15D0052
IAB-05830-LWS18F15E0020
IAB-05830-LWS18F15F0002
IAB-05830-LWS18F15F0039
IAB-05830-LWS18F15G0005
IAB-05830-LWS18F15G0015
IAB-05830-LWS18F15H0006
IAB-05830-LWS18F15H0037
IAB-05830-LWS18F15H0051
IAB-05830-LWS18F15J0026
IAB-05830-LWS18F15L0007
IAB-05830-LWS18S14G0046
IAB-05830-LWS18S15A0021
IAB-05830-U18F14E0030
IAB-05830-U18F14H0019
IAB-05830-U18F14J0038
IAB-05830-U18F14K0012
IAB-05830-U18F14K0019
IAB-05830-U18F15D0030
IAB-05830-U18F15E0017
IAB-05840-LWS18F14A0025
IAB-05840-LWS18F14A0026
IAB-05840-LWS18F14A0030
IAB-05840-LWS18F14A0049
IAB-05840-LWS18F14A0050
IAB-05840-LWS18F14A0051
IAB-05840-LWS18F14A0054
IAB-05840-LWS18F14A0057
IAB-05840-LWS18F14A0066
IAB-05840-LWS18F14A0067
IAB-05840-LWS18F14D0045
IAB-05840-LWS18F14E0004
IAB-05840-LWS18F14E0006
IAB-05840-LWS18F14E0016
IAB-05840-LWS18F14E0017
IAB-05840-LWS18F14E0052
IAB-05840-LWS18F14F0017
IAB-05840-LWS18F14F0047
IAB-05840-LWS18F14F0049
IAB-05840-LWS18F14F0080
IAB-05840-LWS18F14G0003
IAB-05840-LWS18F14G0004
IAB-05840-LWS18F14G0021
IAB-05840-LWS18F14G0037
IAB-05840-LWS18F14G0055
IAB-05840-LWS18F14G0056
IAB-05840-LWS18F14G0068
IAB-05840-LWS18F14G0070
IAB-05840-LWS18F14G0071
IAB-05840-LWS18F14G0076
IAB-05840-LWS18F14H0009
IAB-05840-LWS18F14H0030
IAB-05840-LWS18F14H0054
IAB-05840-LWS18F14H0055
IAB-05840-LWS18F14H0060
IAB-05840-LWS18F14H0061
IAB-05840-LWS18F14J0003
IAB-05840-LWS18F14J0005
IAB-05840-LWS18F14J0037
IAB-05840-LWS18F14K0006
IAB-05840-LWS18F14M0001
IAB-05840-LWS18F14M0014
IAB-05840-LWS18F14M0032
IAB-05840-LWS18F15A0005
IAB-05840-LWS18F15A0011
IAB-05840-LWS18F15A0026
IAB-05840-LWS18F15A0034
IAB-05840-LWS18F15B0005
IAB-05840-LWS18F15B0008
IAB-05840-LWS18F15B0010
IAB-05840-LWS18F15B0018
IAB-05840-LWS18F15B0020
IAB-05840-LWS18F15B0027
IAB-05840-LWS18F15C0002
IAB-05840-LWS18F15C0007
IAB-05840-LWS18F15C0010
IAB-05840-LWS18F15C0015
IAB-05840-LWS18F15C0024
IAB-05840-LWS18F15C0030
IAB-05840-LWS18F15C0036
IAB-05840-LWS18F15D0017
IAB-05840-LWS18F15D0032
IAB-05840-LWS18F15D0034
IAB-05840-LWS18F15D0043
IAB-05840-LWS18F15D0049
IAB-05840-LWS18F15E0003
IAB-05840-LWS18F15E0011
IAB-05840-LWS18F15E0014
IAB-05840-LWS18F15E0023
IAB-05840-LWS18F15E0029
IAB-05840-LWS18F15E0037
IAB-05840-LWS18F15F0011
IAB-05840-LWS18F15F0017
IAB-05840-LWS18F15F0021
IAB-05840-LWS18F15F0032
IAB-05840-LWS18F15G0001
IAB-05840-LWS18F15G0013
IAB-05840-LWS18F15G0021
IAB-05840-LWS18F15G0028
IAB-05840-LWS18F15G0034
IAB-05840-LWS18F15H0010
IAB-05840-LWS18F15H0015
IAB-05840-LWS18F15H0021
IAB-05840-LWS18F15H0024
IAB-05840-LWS18F15H0033
IAB-05840-LWS18F15J0013
IAB-05840-LWS18F15J0028
IAB-05840-LWS18F15J0038
IAB-05840-LWS18F15J0044
IAB-05840-LWS18F15J0049
IAB-05840-LWS18F15K0001
IAB-05840-LWS18F15K0007
IAB-05840-LWS18F15L0002
IAB-05840-LWS18S14G0068
IAB-05840-LWS18S14M0001
IAB-05840-LWS18S15C0002
IAB-05840-U18F14B0044
IAB-05840-U18F14B0045
IAB-05840-U18F14E0060
IAB-05840-U18F14F0019
IAB-05840-U18F14G0067
IAB-05840-U18F14H0002
IAB-05840-U18F14J0026
IAB-05840-U18F15A0033
IAB-05840-U18F15B0009
IAB-05840-U18F15B0019
IAB-05840-U18F15C0012
IAB-05840-U18F15D0016
IAB-05840-U18F15D0037
IAB-05840-U18F15D0044
IAB-05840-U18F15F0001
IAB-06830-U18F13M0016
IAB-06830-U18F14A0017
IAB-06830-U18F14A0018
IAB-06830-U18F14A0022
IAB-06830-U18F14A0046
IAB-06830-U18F14E0054
IAB-06830-U18F14E0070
IAB-06830-U18F14G0038
IAB-06830-U18F14G0078
IAB-06830-U18F14H0007
IAB-06830-U18F14J0007
IAB-06830-U18F14J0025
IAB-06830-U18F14K0016
IAB-06830-U18F15A0035
IAB-06830-U18F15B0006
IAB-06830-U18F15B0014
IAB-06830-U18F15C0019
IAB-06830-U18F15E0028
IAB-06830-U18F15F0016
IAB-06830-U18F15G0007
IAB-06830-U18F15H0009
IAB-06830-U18F15H0035
IAB-06840-U18F13M0017
IAB-06840-U18F13M0019
IAB-06840-U18F13M0021
IAB-06840-U18F14A0012
IAB-06840-U18F14A0013
IAB-06840-U18F14A0015
IAB-06840-U18F14A0016
IAB-06840-U18F14A0044
IAB-06840-U18F14A0047
IAB-06840-U18F14B0042
IAB-06840-U18F14B0043
IAB-06840-U18F14D0068
IAB-06840-U18F14E0005
IAB-06840-U18F14E0007
IAB-06840-U18F14E0031
IAB-06840-U18F14E0053
IAB-06840-U18F14E0069
IAB-06840-U18F14F0030
IAB-06840-U18F14F0031
IAB-06840-U18F14F0066
IAB-06840-U18F14G0020
IAB-06840-U18F14G0039
IAB-06840-U18F14G0066
IAB-06840-U18F14H0003
IAB-06840-U18F14H0010
IAB-06840-U18F14H0023
IAB-06840-U18F14H0024
IAB-06840-U18F14H0056
IAB-06840-U18F14J0006
IAB-06840-U18F14J0016
IAB-06840-U18F14J0027
IAB-06840-U18F14J0051
IAB-06840-U18F15A0008
IAB-06840-U18F15A0015
IAB-06840-U18F15A0023
IAB-06840-U18F15B0003
IAB-06840-U18F15B0007
IAB-06840-U18F15B0021
IAB-06840-U18F15C0006
IAB-06840-U18F15C0011
IAB-06840-U18F15C0027
IAB-06840-U18F15D0010
IAB-06840-U18F15D0019
IAB-06840-U18F15D0045
IAB-06840-U18F15E0002
IAB-06840-U18F15E0012
IAB-06840-U18F15F0008
IAB-06840-U18F15F0028
IAB-06840-U18F15F0038
IAB-06840-U18F15F0041
IAB-06840-U18F15G0016
IAB-06840-U18F15G0027
IAB-06840-U18F15H0005
IAB-06840-U18F15H0020
IAB-06840-U18F15H0032
IAB-06840-U18F15H0041
IAB-06840-U18F15J0007
IAB-06840-U18F15J0010
IAB-06840-U18F15J0021
IAB-06840-U18F15J0029
IAB-06840-U18F15J0039
IAB-06840-U18F15J0056
IAB-06840-U18F15K0016
IAB-06840-U18F15K0032
IAB-06840-U18F15L0001
IAB-06840-U18F15L0010
IAB-S730C18F14A0041
IAB-S730C18F14C0003
IAB-S730C18F14C0006
IAB-S730C18F14C0021
IAB-S730C18F14C0026
IAB-S730C18F14C0027
IAB-S730C18F14C0028
IAB-S730C18F14E0039
IAB-S730C18F14E0055
IAB-S730C18F14E0058
IAB-S730C18F14F0035
IAB-S730C18F14F0038
IAB-S730C18F14F0054
IAB-S730C18F14G0057
IAB-S730C18F14G0077
IAB-S730C18F14H0011
IAB-S730C18F15B0023
IAB-S730C18F15C0001
IAB-S730C18F15C0008
IAB-S730C18F15C0026
IAB-S730C18F15D0028
IAB-S730C18F15F0027
IAB-S730C18F15F0037
IAB-S730C18F15G0003
IAB-S730C18F15G0011
IAB-S730C18F15G0032
IAB-S730C18F15H0046
IAB-S730C18F15M0009
IAK-0684518F14A0037
IAK-0684518F14B0040
IAK-0684518F14E0027
IAK-0684518F14F0027
IAK-0684518F14F0028
IAK-S7IT18F14A0028
IAK-S7IT18F14B0008
IAK-S7IT18F14D0003

Consumers

Teleflex Incorporated
recalls@teleflex.com
1-866-246-6990

Media

Jake Elguicze
610-948-2836