Stop using now Medical device recall · FDA · Published June 24, 2026

Medtronic EOPA Arterial Cannula Recall: Pinhole leaks risk serious injury during surgery

Medtronic recalls EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR for possible pinhole leaks during cardiopulmonary bypass that could cause bleeding, vessel damage, or organ failure.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2806-2026Medical device Medtronic Perfusion Systems ›

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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.

✎ GovInfoNow plain-language explainer

Medtronic is recalling a specific arterial cannula used in heart surgery for possible pinhole leaks that could cause bleeding, vessel damage, or organ failure. This is serious because the cannula is critical during heart surgery and leaks could lead to life-threatening complications. Read more at govinfonow.com/recall/169212-medtronic-eopa-arterial-cannula-recall-pinhole-leaks-risk-serious-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/169212-medtronic-eopa-arterial-cannula-recall-pinhole-leaks-risk-serious-injury · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2806-2026

Cite this page

“Medtronic EOPA Arterial Cannula Recall: Pinhole leaks risk serious injury during surgery.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/169212-medtronic-eopa-arterial-cannula-recall-pinhole-leaks-risk-serious-injury. Based on FDA recall #Z-2806-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2806-2026%22&limit=1).

The FDA announced on June 24, 2026, that Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR units due to potential pinhole leaks. The agency said the hazard may include hypovolemia, vessel laceration, or organ dysfunction during cardiopulmonary bypass.

How to tell if you have it

Brand: Medtronic Perfusion Systems
Product: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR
Model Number: 77422
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
Units affected: 21,290

The hazard

According to the FDA, 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.

Context

GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since 2017-06-22. Other recent recalls of similar products include Medtronic Bio-Medicus Adult Cannula Kit Recall (2026-05-25), Medtronic Octopus Evolution Tissue Stabilizer Model TS2000 Recall (2026-05-12), and Medtronic DLP Cannula Recall (2026-04-21). Other recent recalls of similar products include Medline Convenience Kits Recall (2026-05-28) and Medline Convenience Kits with Swan-Ganz Catheters Recalled Due to Leak Risk (2026-05-28).

How to tell if you have this one

Check for the model number 77422 on the cannula. The UDI-DI is 20763000135632 with specific lot numbers listed in the recall notice. This product was sold for use with cardiopulmonary bypass systems.

Brand
Medtronic Perfusion Systems
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-2806-2026	EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422; 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	21,290 units
Z-2807-2026	EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522; 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	11,720 units
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 77622; 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	13,510 units
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; UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945	3,110 units
Z-2810-2026	EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222; 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	3,621 units
Z-2811-2026	EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322; UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787	1,424 units

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately stop using the recalled EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR if you have it.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

Jun 24, 2026Firm started the recall
Jul 27, 2026FDA classified it Class II
Aug 5, 2026Published in FDA’s Enforcement Report
Aug 11, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/169212-medtronic-eopa-arterial-cannula-recall-pinhole-leaks-risk-serious-injury">Medtronic EOPA Arterial Cannula Recall: Pinhole leaks risk serious injury during surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2806-2026 (June 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2806-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.