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