Arrow International Recalls 7FR Percutaneous Thrombolytic Device Kits

U.S. Food and Drug Administration sent this bulletin at 12/03/2021 02:01 PM EST

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FDA - Center for Devices and Radiological Health

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Arrow International Inc Recalls Arrow‐Trerotola Over‐The‐Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation

Arrow International Inc is recalling the Arrow‐Trerotola Over‐The‐Wire 7FR PTD Kits due to the risk of the inner part of the catheter separating, which may fracture and detach, and block the vessels. If this happens, this could lead to serious adverse events such as embolization, vessel damage, need for additional medical procedures, and possibly death.

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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.  

Questions?

Customers who have questions about this recall should contact Teleflex customer service by phone at 1-866-396-2111, by fax at 1-855-419-8507, or by email at Recalls@teleflex.com.