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

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) has announced a worldwide recall of its Arrow-Trerotola™ Over-The-Wire PTD® Kit due to a defect where the inner lumen can detach from the device’s basket. This recall affects products manufactured between October 2019 and July 2021, classified as a Class I recall by the FDA. The company received seven complaints, with no reported long-term complications. Consumers are advised to discontinue use and return all affected products. The recall notice, including product codes and lot numbers, is available on their website.

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• Worldwide recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit due to product defect.
• FDA classified the recall as Class I, indicating serious health consequences may arise.
• Seven customer complaints reported, highlighting potential risks associated with the defective product.

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 Code	Lot Number	Unique Device Identifier (UDI) #
PT-12709-WC	13F19K0564	(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-HFWC	13F19K0369	(01)10801902121292 (17)210930 (10)13F19K0369
	13F20A0323	(01)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-W	13F19M0129	(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-WC	13F19J0656	(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 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. Complete and submit the report Online: www.fda.gov/medwatch/report.htm, or via 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 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

investor.relations@teleflex.com 
610-948-2836

FAQ

What is the Arrow-Trerotola™ Over-The-Wire PTD® Kit recall about?

The recall is due to a defect where the inner lumen can detach from the device's basket, which may lead to health risks.

When was the recall for the Arrow-Trerotola™ PTD Kit initiated?

The recall was initiated on September 20, 2021.

What classification has the FDA given to the Arrow-Trerotola™ PTD Kit recall?

The FDA classified the recall as Class I, indicating there is a reasonable probability of serious health consequences.

How many complaints have been received regarding the Arrow-Trerotola™ PTD Kit?

Seven customer complaints have been reported concerning the defect.

What should consumers do if they have the affected Arrow-Trerotola™ PTD Kit?

Consumers should discontinue use and return all affected products to Teleflex.