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WAYNE, Pa., November 26, 2021 (GLOBE NEWSWIRE) – Teleflex Incorporated (NYSE: TFX), one of the world’s leading providers of medical technology for critical care and surgery, has announced a global recall of Arrow-Trerotola â„¢ Over-The -Percutaneous thrombolytic device of the Wire PTD® kit: 7FR. The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, combined with the Arrow Rotator Drive Unit, provides mechanical decoagulation of native arteriovenous (AV) fistulas and synthetic dialysis grafts.
The products affected by the recall are as follows. Additional details on how to identify affected products can be found in the recall letter.
| Product code | Batch 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) 20131 (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) 20131 (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 that the PTD internal light (orange) has detached from the device basket. Arrow-Trerotola ™ Over-The-Wire PTD® Kit percutaneous thrombolytic device: 7FR manufactured from October 2019 to July 2021 are subject to recall.
If the orange internal lumen detaches from the basket, the health consequences depend on the embolization of the fractured tip component and where. In most cases, the embolization is local to the target site of treatment, allowing recovery with additional intervention and consequent delay in treatment. In some cases, the embolization may be central or peripheral and cause or threaten to cause local ischemia. Such an event might require a more complex, catheter-based intervention for recovery, or rarely, surgical recovery. The light component is radiopaque.
As of November 2021, a total of seven customer complaints had been received for this issue. In one complaint, a trap 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 United States Food and Drug Administration (FDA) classified the recall of Arrow-Trerotola â„¢ Over-The-Wire PTD®: 7FR Percutaneous Thrombolytic Device as a Class I recall. FDA sets recall class I like: “a situation in which there is a reasonable probability that the use or exposure to a nonconforming product will result in serious adverse health or death consequences. “
Consumers who have an affected product should immediately identify all patients currently exposed to the use of that product, stop using it, and return all affected products to Teleflex. The recall notice, with a list of affected product codes and lot numbers, can be found via the following link: https://teleflex.widen.net/s/mdr28xv2pr/fsn—eif-000484_us
Consumers with questions can contact the company at 1-866-396-2111; 8:00 a.m. to 7:00 p.m. ET, Monday to Friday or by email at [email protected]
Adverse reactions or quality issues encountered while using this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program, either online, by regular mail, or by fax. Complete and submit the report In line: www.fda.gov/medwatch/report.htm, or via Regular mail or fax: Download the form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a report form, then complete and return to the address on the pre-addressed form, or send – 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 life of people. We apply goal-driven innovation – a relentless pursuit of identifying unmet clinical needs – for the benefit of patients and healthcare providers. Our portfolio is diverse, with solutions in the areas of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgery, urology and respiratory care . Teleflex employees around the world are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Teleflex is home to Arrow®, Deknatel®, LMA®, Pilling®, QuikClot®, Rüsch®, UroLift® and Weck® – trusted brands united by a common goal.
Forward-looking statements
All statements in this press release that do not describe historical facts may constitute forward-looking statements. All forward-looking statements contained in this document are based on the current beliefs and expectations of our management, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or the actions of the company 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 subsidiaries, in the United States and / or in other countries.
© 2021 Teleflex Incorporated. All rights reserved.
Source:
Teleflex Incorporated:
Laurent Keusch
Vice-President, Investor Relations and Strategic Development
John Hsu, CFA
Vice-President, Investor Relations
[email protected]
610-948-2836
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