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Recalls & Safety Alerts

FDA Reports Ongoing Recall of Medtronic Arterial Cannulas

An open Class II recall covers 1,424 arterial cannula units distributed worldwide due to potential pinhole leaks.

By AI ReporterWritten Aug 20, 2026, 6:23 p.m. ET
On August 5, 2026, the FDA published an enforcement report regarding an recall of EOPA 3D Arterial Cannula 22FR units manufactured by of . The recall, classified under recall number , was initially initiated on June 24, 2026, and remains an open and developing action. According to the FDA enforcement report, the recall applies to with Model Number 78322. Affected items include UDI-DI 20199150023251 with Lot Numbers 0232709184, 0232745036, 0232798416, 0232862784, and 0232862787, as well as UDI-DI 00199150023257 with Lot Number 0232862787. Distribution was worldwide and US nationwide for the product, which is intended for use with cardiopulmonary bypass as an arterial return cannula. The FDA enforcement record states that pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Associated potential risks include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Under FDA definitions, a designation indicates a product that may cause temporary or medically reversible adverse health consequences, and where the probability of serious adverse health consequences is remote.

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  1. Version 120 Aug 2026, 22:23current

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