Skip to main content
Recall Canary
Medtronic EOPA Arterial Cannula 22FR
← Back to all recalls
MEDICAL DEVICE RECALLMODERATE

Medtronic EOPA Arterial Cannula 22FR

Medtronic recalls EOPA 22FR arterial cannula (Model 77422) over pinhole leak risk during bypass.

What to do

If you have the affected EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, Model Number 77422, stop using it immediately and contact Medtronic Perfusion Systems for instructions on return and replacement.

Recalled
Listed
Updated
Recall No.
Z-2809-2026
Agency
FDA
Firm
Medtronic Perfusion Systems
Recall ID
99320
Status
ONGOING

Why it was recalled

Medtronic is recalling the EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, Model Number 77422, due to reports of pinhole leaks in the wire-wound body that can occur during cardiopulmonary bypass procedures. These leaks may lead to serious patient harm, including blood loss or air embolism.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 777220232657469, 0232670800, 0232744945, 0232798410, 0232862769, 0232985251, 0233116924, 0233116931Z-2809-202620199150023312, 0232657469, 0232670800, 0232744945, 0232798410, 0232862769, 0232985251, 0233116924, 0233116931, 00199150023318, 0232744945
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 783220232709184, 0232745036, 0232798416, 0232862784, 0232862787Z-2811-202620199150023251, 0232709184, 0232745036, 0232798416, 0232862784, 0232862787, 00199150023257, 0232862787
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 782220232602300, 0232602383, 0232612916, 0232680078, 0232708967, 0232709001, 0232910880, 0232910881, 0232910882, 0233077983, 0233245850, 0233245860, 0233245980Z-2810-202620763000135700, 0232602300, 0232602383, 0232612916, 0232680078, 0232708967, 0232709001, 0232910880, 0232910881, 0232910882, 0233077983, 0233245850, 0233245860, 0233245980, 00763000135706, 0232612916, 0232709001
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 776220232601501, 0232601510, 0232601549, 0232601550, 0232602178, 0232602290, 0232602302, 0232910952, 0232910953, 0232910954, 0232910955, 0233244075, 0233244301, 0233244531, 0233286362, 0233286374, 0233286390, 0233409034, 0233416071, 0233528731Z-2808-202620763000135670, 0232601501, 0232601510, 0232601549, 0232601550, 0232602178, 0232602290, 0232602302, 0232910952, 0232910953, 0232910954, 0232910955, 0233244075, 0233244301, 0233244531, 0233286362, 0233286374, 0233286390, 0233409034, 0233416071
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 774220232446429, 0232446444, 0232486752, 0232601515, 0232601516, 0232601522, 0232601586, 0232601591, 0232601593, 0232602180, 0232798265, 0232798353, 0232849583, 0232894981, 0232895082, 0232902694, 0232902697, 0232902698, 0232902700, 0232902803, 0232902805, 0232902846, 0232985469, 0233009922, 0233108251, 0233116991, 0233127352, 0233334923, 0233334966, 0233426694, 0233426695, 0233528727Z-2806-202620763000135632, 0232446429, 0232446444, 0232486752, 0232601515, 0232601516, 0232601522, 0232601586, 0232601591, 0232601593, 0232602180, 0232798265, 0232798353, 0232849583, 0232894981, 0232895082, 0232902694, 0232902697, 0232902698, 0232902700
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 775220233286436, 0232709428, 0232744924, 0232745061, 0232745092, 0232798556, 0232862763, 0232862778, 0232862794, 0232862798, 0232903216, 0232903291, 0232903383, 0232990983, 0233286318, 0233286414, 0233427120, 0233528730, 0233553623, 0233556386, 0233585113, 0233585114, 0232670802Z-2807-202600199150023288, 0233286436, 20199150023282, 0232709428, 0232744924, 0232745061, 0232745092, 0232798556, 0232862763, 0232862778, 0232862794, 0232862798, 0232903216, 0232903291, 0232903383, 0232990983, 0233286318, 0233286414, 0233286436, 0233427120

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

Other recent recalls from Medtronic Perfusion Systems

All recalls from Medtronic Perfusion Systems

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification