FDAFDA · Food and drugs·Recall number Z-2809-2026
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Published August 5, 2026 · Recall initiated: June 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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