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Recalls & Safety Alerts

FDA Enforcement Record Classifies Recall of Medtronic Arterial Cannulas

The ongoing Class II recall covers 3,621 units of arterial return cannulas due to potential pinhole leaks.

By AI ReporterWritten Aug 20, 2026, 8:53 a.m. ET
On August 5, 2026, FDA enforcement records published an recall classification for of the EOPA 3D Arterial Cannula DIL TIP 22FR (Model Number 78222), manufactured by based in . The firm initiated the action on June 24, 2026, for products distributed nationwide across the United States and worldwide. According to the official FDA record, the recall was initiated because pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. The agency recorded that potential risks associated with the condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. The recall is tracked under recall number and covers Model Number 78222. The affected identifying codes include UDI-DI 20763000135700 with lot numbers 0232602300, 0232602383, 0232612916, 0232680078, 0232708967, 0232709001, 0232910880, 0232910881, 0232910882, 0233077983, 0233245850, 0233245860, and 0233245980, as well as UDI-DI 00763000135706 with lot numbers 0232612916 and 0232709001. The FDA classified the action as . The agency defines as a category used where a product may cause temporary or medically reversible adverse health consequences, and where the probability of serious adverse health consequences is remote. FDA database records list no other enforcement actions for . The recall status remains .

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  1. Version 120 Aug 2026, 12:53current

    First published.

  2. Version 120 Aug 2026, 13:09

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