FDA MedWatch - Arrow -Trerotola Percutaneous Thrombolytic Device by Arrow International:
U.S. Food and Drug Administration sent this bulletin at 02/24/2022 03:10 PM EST
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: Arrow - Trerotola Percutaneous Thrombolytic Device by Arrow International: Class I Recall - Due to Risk of Tip Damage During Use
AUDIENCE: Patient, Health Professional, Risk Manager
ISSUE: Arrow-International (a subsidiary of Teleflex) is recalling the Arrow-Trerotola Percutaneous Thrombolytic Device due to risk of tip damage during use, which may result in tip detachment from the basket. This could potentially lead to vascular injuries, including obstruction (blockage) of the vessel, additional thrombosis (blood clot), ischemia (inadequate blood supply), infarction (heart attack), infection or death.
As of December 2021, a total of 35 complaints reporting tip separation have been received. Of these 35 complaints, 14 reported injuries, and nine complaints involved use of a stent (support structure) to manage the separated tip.
No deaths have been reported at this time.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The Arrow-Trerotola Percutaneous Thrombolytic Device consists of a catheter with an expandable basket attached to a drive cable that is used in with a low-speed, battery-operated rotator unit to remove blood clots in native arterio-venous fistulae and synthetic dialysis grafts.
RECOMMENDATIONS:In January 2022, Teleflex sent an Urgent Medical Recall Letter to affected customers informing them of the product issue and potential risks to health.
Teleflex asked customers to take the following actions:
Stop use and distribution of the product and quarantine the product immediately.
Report adverse reactions or quality problems experienced with the use of this product to Teleflex Customer Service or to the FDA’s MedWatch Adverse Event.
Pass recall notice to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please consider end users, clinicians, risk managers, supply chain and distribution centers.
Return all product in scope of recall to Teleflex.
Maintain awareness of this notice until all required actions have been completed by your organization.
Complete the Field Safety Corrective Action Acknowledgement Form and return to Teleflex.
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:
