FDAClass IIAugust 5, 2026

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall

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

Why was EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Recalling firm
Medtronic Perfusion Systems
Quantity
3,110 units
Distribution
Worldwide - US Nationwide distribution.
Recall date
August 5, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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