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Teleflex Recalls Certain Arrow-Trerotola Over-The-Wire PTD Kit

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Teleflex Inc., a provider of medical technologies for critical care and surgery, is recalling Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR, the U.S. Food and Drug Administration said.

The Arrow-Trerotola Percutaneous Thrombolytic Device or PTD Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous or AV fistulae and synthetic dialysis grafts.

The recall involves products with Product Code PT-12709-WC, PT-65709-HFWC, PT-65709-W, and PT-65709-WC. The products were manufactured from October 2019 through July 2021.

Teleflex initiated the recall following reports indicating that the PTD's Inner lumen (orange) detached from the device's basket. As of November 2021, the company has received a total of seven customer complaints for this issue. In one complaint, a snare was used by the clinician to retrieve the detached lumen from the patient. However, no long-term patient complications have been reported.

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.

The agency noted that such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval. The lumen component is radio-opaque.

On November 18, the FDA classified the recall of Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as a Class I recall.

Consumers are urged to discontinue use of the product, and return all affected product to Teleflex.

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