Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula 22FR model 78322 due to potential pinhole leaks during cardiopulmonary bypass that could cause hypovolemia, vessel laceration, or organ dysfunction.
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 22FR model 78322 used in heart surgeries. Pinhole leaks during cardiopulmonary bypass could lead to serious complications like low blood volume, vessel damage, or organ issues.
Pinhole leaks in the cannula during heart surgery could cause blood loss (hypovolemia), damage to blood vessels, low blood pressure, tissue damage, or organ failure.
Healthcare professionals using this cannula during heart surgery are most at risk. Patients undergoing cardiopulmonary bypass procedures with this model may be affected.
Check for model number 78322 on the cannula. Look for lot numbers 0232709184, 0232745036, 0232798416, 0232862784, 0232862787, or UDI-DI 20199150023251 and 00199150023257.
Look for model number 78322 on the cannula.
Reach out to Medtronic Perfusion Systems for specific guidance on next steps.
The recall states pinhole leaks may occur during cardiopulmonary bypass, which could lead to serious complications. Do not use until contacted by Medtronic.
Check the model number and lot numbers listed in the recall. Contact Medtronic Perfusion Systems for specific instructions.
Look for model number 78322 and lot numbers 0232709184, 0232745036, 0232798416, 0232862784, or 0232862787.
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-2811-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2811-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
