Elevated site urgencyFDA Class II

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722

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.

Agency
FDA Device
Recall date
Jun 24, 2026
Status
Ongoing
Company
Medtronic Perfusion Systems

1. What product was recalled?

EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322

EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322

Quantity: 1,424 units

Code or lot text: UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787

LOT
Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787
LOT
Lot Numbers: 0232862787
LOT
UDI-DI: 00199150023257
LOT
UDI-DI: 20199150023251
RECALL-NUMBER
Z-2811-2026

EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222

EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222

Quantity: 3,621 units

Code or lot text: UDI-DI: 20763000135700, Lot Numbers: 0232602300 0232602383 0232612916 0232680078 0232708967 0232709001 0232910880 0232910881 0232910882 0233077983 0233245850 0233245860 0233245980; UDI-DI: 00763000135706, Lot Numbers: 0232612916 0232709001

LOT
Lot Numbers: 0232602300 0232602383 0232612916 0232680078 0232708967 0232709001 0232910880 0232910881 0232910882 0233077983 0233245850 0233245860 0233245980
LOT
Lot Numbers: 0232612916 0232709001
LOT
UDI-DI: 00763000135706
LOT
UDI-DI: 20763000135700
RECALL-NUMBER
Z-2810-2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422

Quantity: 21,290 units

Code or lot text: UDI-DI: 20763000135632, Lot Numbers: 0232446429 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 0233528727; UDI-DI: 00763000135638, Lot Numbers: 0232446444 0232798353 0232895082 0232902697 0232902803 0232902846 0232985469 0233127352 0233334923

LOT
Lot Numbers: 0232446429 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 0233528727
LOT
Lot Numbers: 0232446444 0232798353 0232895082 0232902697 0232902803 0232902846 0232985469 0233127352 0233334923
LOT
UDI-DI: 00763000135638
LOT
UDI-DI: 20763000135632
RECALL-NUMBER
Z-2806-2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

Quantity: 11,720 units

Code or lot text: UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802

LOT
Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802
LOT
Lot Numbers: 0233286436
LOT
UDI-DI: 00199150023288
LOT
UDI-DI: 20199150023282
RECALL-NUMBER
Z-2807-2026

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622

Quantity: 13,510 units

Code or lot text: UDI-DI: 20763000135670, Lot Numbers: 0232601501 0232601510 0232601549 0232601550 0232602178 0232602290 0232602302 0232910952 0232910953 0232910954 0232910955 0233244075 0233244301 0233244531 0233286362 0233286374 0233286390 0233409034 0233416071 0233528731

LOT
Lot Numbers: 0232601501 0232601510 0232601549 0232601550 0232602178 0232602290 0232602302 0232910952 0232910953 0232910954 0232910955 0233244075 0233244301 0233244531 0233286362 0233286374 0233286390 0233409034 0233416071 0233528731
LOT
UDI-DI: 20763000135670
RECALL-NUMBER
Z-2808-2026

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722

Quantity: 3,110 units

Code or lot text: UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945

LOT
Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931
LOT
Lot Numbers: 0232744945
LOT
UDI-DI: 00199150023318
LOT
UDI-DI: 20199150023312
RECALL-NUMBER
Z-2809-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is 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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.