FDA Class I Recall: Teleflex Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR

Dec. 2, 2021

Teleflex Incorporated 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 U.S. Food and Drug Administration (FDA) has classified the recall of Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as a Class I recall.

Teleflex initiated its own voluntary Field Safety Corrective Action on September 20, 2021—a worldwide recall, due to reports received indicating that the PTD’s Inner lumen (orange) detached from the device’s basket.

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.

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.

FDA recall announcement

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