The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD)
- Model Number: See Recall Database Entry
- Manufacturing Dates: January 1, 2020 to December 31, 2021
- Distribution Dates: February 1, 2020 to December 31, 2021
- Devices Recalled in the U.S.: 24,895
- Date Initiated by Firm: December 22, 2021
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) consists of a catheter with an expandable basket attached to a drive cable. The catheter is used in with a low-speed, battery-operated rotator unit to remove blood clots in native arterio-venous fistulae and synthetic dialysis grafts.
Reason for Recall
Arrow-International, LLC (a subsidiary of Teleflex Inc.) 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.
Who May Be Affected
- Health care providers using the Arrow-Trerotola PTD
- Patients receiving care using the Arrow-Trerotola PTD
What to Do
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 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 by FAX at 1-855-419-8507 or by email at Recalls@teleflex.com.
Customers with questions about this recall should contact Teleflex, Inc. Service by telephone at 1-866-396-2111 or by email at Recalls@teleflex.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.