Arrow International Inc, a subsidiary of Teleflex, has recalled a total of 3,241 Arrow-Trerotola Over-the-Wire 7FR Percutaneous Thrombolysis (PTD) kits due to the risk of the orange inner lumen of the catheter tip becoming detached from the basket.
The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall, the most severe type due to the risk of serious injury or death.
The recalled kits contain a rotatable catheter with an outer sheath and an inner cable with a self-expanding basket. The Arrow Trerotola PTD Catheter is used with the Arrow Rotator Drive Unit to remove blood clots in patients with arteriovenous fistulas and synthetic dialysis grafts.
“If the orange inner lumen becomes detached from the basket, it can break and loosen and block the blood vessels,” the recall notice said on the FDA website.
“If the orange inner lumen separates from the basket, the health consequences will depend on where the broken tip component is embolizing. If the embolization occurs locally at the treatment target site, recovery can be attempted, which requires additional intervention and, consequently, a delay in therapy, ”the agency notes.
“In some cases, the embolization could be central, or possibly even affect the heart or pulmonary arteries. This can lead to serious side effects such as vascular damage, the need for additional medical procedures, or possibly death, ”says the agency.
To date, seven complaints and no injuries or deaths have been reported for this device.
The recalled devices were distributed in the United States between November 1, 2019 and July 31, 2021. The product codes and lot numbers of the devices are listed on the FDA website. See Recalling a Database Entry
Teleflex has sent an urgent security notice to customers asking them to review inventory for affected products and remove and quarantine all recalled products.
Customers are also asked to fill out the attached confirmation form and fax it to 1-855-419-8507 (attention: customer service) or email it to email@example.com.
Customers with a recall service will be contacted by a company representative with instructions on how to return a recalled product.
Customers with questions about this recall should contact Teleflex Customer Service by calling 1-866-396-2111, faxing 1-855-419-8507, or emailing Recalls@teleflex.com.
Healthcare providers can report any side effects or quality issues encountered while using these devices to the FDA’s MedWatch program.