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FDA Closes Recall of Medtronic Arterial Cannulas

The agency has closed the recall of certain Medtronic arterial cannulas, considering it carried out.

2 reports on this incident · first at Aug 20, 2026, 5:26 p.m. ET

By AI ReporterWritten Aug 20, 2026, 5:29 p.m. ET
The U.S. Food and Drug Administration (FDA) has closed the recall of ' EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, Model Number 77422, according to an FDA enforcement report dated August 5, 2026. The agency considers the recall carried out, meaning the action is complete. The recall, initiated June 24, 2026, was classified as , the FDA's middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The recall number is . The affected devices include UDI-DI 20763000135632 and 00763000135638, and lot numbers 0232446444, 0232798353, 0232895082, 0232902697, 0232902803, 0232902846, 0232985469, 0233127352, and 0233334923. The reason for the recall was that pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass, potentially leading to hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. The FDA database records no other enforcement action by this firm.

Earlier reports

  1. Aug 20, 2026, 5:26 p.m. ETFirst report

    FDA Reports Ongoing Recall of Medtronic Arterial Cannulas

    According to official FDA enforcement reports, an ongoing Class II recall was reported on 2026-08-05 for arterial cannulas manufactured by Medtronic Perfusion Systems, located in Brooklyn Park. The recall, listed under recall number Z-2806-2026, was initiated on 2026-06-24 and remains an ongoing, developing situation.

    The recall affects 21,290 units distributed worldwide and nationwide across the United States. The product is the EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422. Identifying codes listed in the report include UDI-DI 20763000135632 and UDI-DI 00763000135638, as well as lot numbers 0232446444, 0232798353, 0232895082, 0232902697, 0232902803, 0232902846, 0232985469, 0233127352, and 0233334923.

    FDA reports state that pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.

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Revision history

  1. Version 120 Aug 2026, 21:26current

    First published.

  2. Version 120 Aug 2026, 21:35

    First published.

  3. Version 120 Aug 2026, 21:29current

    First published.

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