Arrow International, LLC Recalls its Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use

U.S. Food and Drug Administration sent this bulletin at 02/23/2022 04:52 PM EST

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CDRH Medical Device Recall

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Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use

Arrow International, LLC 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.

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.

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Questions?

If you have questions about this recall, contact Teleflex, Inc. Customer Service by telephone at 1-866-396-2111 or by email at Recalls@teleflex.com.