Medtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR due to pinhole leaks during cardiopulmonary bypass that may cause hypovolemia, vessel laceration, or organ dysfunction. Affected units have specific model and lot numbers.
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.
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR used in heart surgery. Pinhole leaks during cardiopulmonary bypass could cause serious complications like bleeding, low blood pressure, or organ damage. This recall affects specific model numbers and lot dates.
Pinhole leaks in the cannula's wire-wound body during heart surgery can lead to blood loss (hypovolemia), vessel tears, low blood pressure, tissue damage, or organ failure. These risks occur because the leak happens while the cannula is connected to the heart-lung machine.
Healthcare professionals using this cannula during heart surgery are most at risk. Patients undergoing cardiopulmonary bypass procedures with this specific model may be affected.
Check for model number 77622 and lot numbers listed in the recall (e.g., 0232601501, 0232601510). This cannula is used with cardiopulmonary bypass systems during heart surgery.
Immediately stop using the EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR if it has the model number 77622 and any of the listed lot numbers.
The model number is 77622.
Affected lot numbers include 0232601501, 0232601510, 0232601549, 0232601550, 0232602178, 0232602290, 0232602302, 0232910952, 0232910953, 0232910954, 0232910955, 0233244075, 0233244301, 0233244531, 0233286362, 0233286374, 0233286390, 0233409034, 0233416071, 0233528731.
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass, which could lead to serious complications like blood loss, vessel laceration, low blood pressure, or organ damage.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2808-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2808-2026 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
