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Medtronic Perfusion Systems: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Nu

Medical DevicesSource: FDA (device) · Date: 2026-08-05

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic Perfusion Systems
Product
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-06-24
Code info
UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945
Product quantity
3,110 units
Voluntary mandated
Voluntary: Firm initiated
City
Brooklyn Park
State
MN
Country
United States
Event id
99320
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