FDA MedWatch - Arrow -Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7R by Teleflex Incorporated:

Class I Recall - Due Inner lumen May Detach From the Device's Basket

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Arrow -Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7R by Teleflex Incorporated: Class I Recall - Due to Inner Lumen Detaching From the Device's Basket AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology, Nephrology ISSUE: Teleflex Incorporated is recalling the Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR manufactured between October 2019 through July 2021. The reason for the recall is due to reports received indicating that PTD's Inner lumen (orange) is detaching 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. Such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval. As of November 2021, 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. For more information about this recall click on red button "Read Recall" below. BACKGROUND: This product, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts. RECOMMENDATIONS:  Medical facilities and hospitals that 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. Health care professionals with questions may contact the company. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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