Teleflex Recalling Certain Arrow-Trerotola Percutaneous Thrombolytic Devices

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By Stephen Nakrosis
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Teleflex Inc. said on Friday that it is announcing a worldwide recall of the Aero-Trerotola Over-the-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR.

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The company said that devices manufactured from October 2019 to July 2021 are subject to the recall.

Teleflex said it initiated a voluntary field safety corrective action on September 20, following reports that “the inner lumen (orange) of the PTD separated from the device basket.”

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“If the orange inner lumen detaches from the basket, the health consequences depend on what and where the fractured tip component is,” the company said. In most cases, the company said, “embolization is local to the treatment target site, allowing recovery with additional interventions and delays resulting from therapy.” In some cases, it said, “recovery may require more complex catheter-based interventions or, more rarely, surgical recovery.”

Teleflex said that as of November 2021, it had received seven customer complaints related to the issue, and “no long-term patient complications have been reported.”

Teleflex also stated “the Aero-trareotola percutaneous thrombolytic device catheter, in combination with the arrow rotator drive unit, allows mechanical declotting of native arteriovenous fistulas and synthetic dialysis grafts.”

Write to Stephen Necrosis at [email protected]

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