Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula DIL TIP 22FR used in cardiopulmonary bypass. Pinhole leaks 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 3D Arterial Cannula DIL TIP 22FR used in heart surgery. Pinhole leaks during surgery could lead to serious complications like low blood volume, vessel damage, or organ failure. This is a critical safety issue for surgical teams using the device.
Pinhole leaks in the wire-wound body during cardiopulmonary bypass can cause blood loss (hypovolemia), vessel laceration or perforation, low blood pressure, tissue damage, or organ dysfunction. These risks are severe in the context of heart surgery where precise blood flow control is critical.
Surgical teams using the EOPA 3D Arterial Cannula DIL TIP 22FR during cardiopulmonary bypass procedures. Patients undergoing heart surgery are at risk if the device leaks during critical operations.
Check for model number 78222 and lot numbers listed in the recall notice (e.g., 0232602300, 0232602383). The device is used with cardiopulmonary bypass systems in heart surgery procedures.
Discontinue use of the EOPA 3D Arterial Cannula DIL TIP 22FR if it has the model number 78222 and any of the listed lot numbers.
The model number is 78222.
Affected lot numbers include 0232602300, 0232602383, 0232612916, 0232680078, 0232708967, 0232709001, 0232910880, 0232910881, 0232910882, 0233077983, 0233245850, 0233245860, 0233245980.
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass, potentially causing hypovolemia, vessel laceration, or organ dysfunction.
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-2810-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2810-2026 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.
