Z-2809-2026 Class II Ongoing
FDA device recall Z-2809-2026 was initiated by Medtronic Perfusion Systems on June 24, 2026 and is designated Class II. Reason for recall: 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, isc… The recall status is ongoing. Affected quantity: 3,110 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2026
- Initiation Date
- June 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,110 units
Product Description
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945