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Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices

Reason for Announcement:

Recall Reason Description

Inner lumen may detach from the device’s basket

Company Name:
Teleflex Incorporated
Brand Name:

Brand Name(s)

Product Description:

Product Description

Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR


Company Announcement

WAYNE, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR. The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

The products involved in the recall are as follows. Additional detail about how to identify the affected products is available in the recall letter.

Product CodeLot NumberUnique Device Identifier (UDI) #
PT-12709-WC13F19K0564(01)20801902156758 (17)210930 (10)13F19K0564
13F20C0094(01)10801902121254 (17)220228 (10)13F20C0094
13F20G0284(01)10801902121254 (17)220630 (10)13F20G0284
13F20L0282(01)10801902121254 (17)221031 (10)13F20L0282
13F21A0497(01)10801902121254 (17)221231 (10)13F21A0497
13F21A0718(01)10801902121254 (17)230131 (10)13F21A0718
13F21F1187(01)10801902121254 (17)230630 (10)13F21F1187
13X21E0008(01)10801902121254 (17)230531 (10)13X21E0008
PT-65709-HFWC13F19K0369(01)10801902121292 (17)210930 (10)13F19K0369
13F20A032301)108019022121292 (17)211231 (10)13F20A0323
13F20B0139(01)10801902121292 (17)220131 (10)13F20B0139
13F20C0594(01)10801902121292 (17)220331 (10)13F20C0594
13F20F0083(01)10801902121292 (17)220531 (10)13F20F0083
13F20F0230(01)10801902121292 (17)220531 (10)13F20F0230
13F20F0577(01)10801902121292 (17)220630 (10)13F20F0577
13F20H0756(01)10801902121292 (17)220831 (10)13F20H0756
13F20K0849(01)10801902121292 (17)221031 (10)13F20K0849
13F20L0283(01)10801902121292 (17)221031 (10)13F20L0283
13F20M0182(01)10801902121292 (17)221231 (10)13F20M0182
13F21A0498(01)10801902121292 (17)221231 (10)13F21A0498
13F21B0158(01)10801902121292 (17)230131 (10)13F21B0158
13F21C0747(01)10801902121292 (17)230331 (10)13F21C0747
13F21E0555(01)108019021212292 (17)230430 (10)13F21E0555
PT-65709-W13F19M0129(01)10801902121315 (17)211130 (10)13F19M0129
13F20B0053(01)108019022121315 (17)220131 (10)13F20B0053
13F20C0595(01)10801902121315 (17)220331 (10)13F20C0595
13F20F0231(01)10801902121315 (17)220531 (10)13F20F0231
13F20G0361(01)10801902121315 (17)220731 (10)13F20G0361
13F20K0632(01)10801902121315 (17)221031 (10)13F20K0632
13F21A0353(01)10801902121315 (17)221231 (10)13F21A0353
13F21C0748(01)10801902121315 (17)230331 (10)13F21C0748
13F21D0721(01)10801902121315 (17)230430 (10)13F21D0721
13F21E0823(01)10801902121315 (17)230531 (10)13F21E0823
13F21F1189(01)10801902121315 (17)230630 (01)13F21F1189
PT-65709-WC13F19J0656(01)20801902156741 (17)210930 (10)13F19J0656
13F19K0342(01)20801902156741 (17)210930 (10)13F19K0342
13F19K0368(01)10801902121308 (17)210930 (10)13F19K0368
13F20C0596(01)10801902121308 (17)220331 (10)13F20C0596
13F20F0081(01)10801902121308 (17)220531 (10)13F20F0081
13F20F0229(01)10801902121308 (17)220531 (10)13F20F0229
13F20F0509(01)10801902121308 (17)220531 (10)13F20F0509
13F20F0578(01)10801902121308 (17)220630 (10)13F20F0578
13F20G0177(01)10801902121308 (17)220630 (10)13F20G0177
13F20G0566(01)10801902121308 (17)220630 (10)13F20G0566
13F20H0531(01)10801902121308 (17)220831 (10)13F20H0531
13F20J0379(01)10801902121308 (17)220831 (10)13F20J0379
13F20L0514(01)10801902121308 (17)221031 (10)13F20L0514
13F21A0354(01)10801902121308 (17)221231 (10)13F21A0354
13F21C0081(01)10801902121308 (17)230228 (10)13F21C0081
13F21C0749(01)10801902121308 (17)230331 (10)13F21C0749
13F21D0870(01)10801902121308 (17)230430 (10)13F21D0870
13F21E0415(01)10801902121308 (17)230430 (10)13F21E0415
13F21F1188(01)10801902121308 (17)230630 (10)13F21F1188

Teleflex initiated this voluntary Field Safety Corrective Action on September 20, 2021 due to reports received indicating that the PTD’s Inner lumen (orange) detached from the device’s basket. Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR manufactured from October 2019 through July 2021 are subject to the recall.

If the orange inner lumen detaches from the basket, health consequences depend upon whether, and where, the fractured tip component embolizes. In most cases, the embolization is local to the treatment target site, allowing retrieval with an additional intervention and consequent delay of therapy. In some cases, the embolization could be central or peripheral and result in, or threaten to cause, local ischemia. Such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval. The lumen component is radio-opaque.

As of November 2021, a total of seven customer complaints have been received for this issue. In one complaint, a snare was used by the clinician to retrieve the detached lumen from the patient. No long-term patient complications have been reported.

On November 18, 2021, the U.S. Food and Drug Administration (FDA) classified the recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR 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.”

Consumers who have affected product should immediately identify all patients that are currently exposed to use of this product, discontinue use, and return all affected product to Teleflex. The recall notice, with a list of affected product codes and lot numbers, can be found through the following link: https://teleflex.widen.net/s/mdr28xv2pr/fsn—eif-000484_us

Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email [email protected].

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
  • Regular Mail or Fax: Download form 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 access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology 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®, LMA®, Pilling®, QuikClot®, Rüsch®, UroLift®, 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, Arrow-Trerotola, Deknatel, LMA, Pilling, PTD, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.

Source:
Teleflex Incorporated:

Lawrence Keusch
Vice President, Investor Relations and Strategy Development

John Hsu, CFA
Vice President, Investor Relations

[email protected]
610-948-2836


Company Contact Information

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Author: FDA

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