Class II U.S. Food and Drug Administration

Medtronic Perfusion Systems EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use recall: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass

Recall published 3 months ago

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.

The hazard: Laceration or amputation hazard

A laceration or amputation risk prompted this notice, which is why the remedy is usually a replacement rather than a repair.

What the notice says: 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.

Why it matters: A blade, edge or moving part can cut the user, or a part can break and come apart in the hand. With powered tools, the same defect that causes a cut can cause a much worse injury.

Symptoms and when to call a doctor

Control bleeding with firm, direct pressure using a clean cloth and raise the limb if you can. Go to an emergency department for a wound that will not stop bleeding, that gapes open, that is deep or dirty, that involves a hand, face or joint, or where feeling or movement has changed. If a body part has been severed, call 911, wrap the part in clean damp gauze, seal it in a bag and keep the bag on ice — never directly on ice.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2810-2026
Published
August 5, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Perfusion Systems
Product type
Medical devices
Units affected
3,621 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
20763000135700, 00763000135706

Products covered by this recall

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

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 20763000135700
  • 00763000135706

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0232612916 0232709001 — 3
  • 621 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 78222 — UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Laceration

Medtronic Perfusion Systems — A laceration or amputation risk prompted this notice, which is why the remedy is usually a replacement rather than a repair.

  1. Stop using the product and unplug it, or take the battery out if it is cordless.
  2. Follow the remedy on this page and keep the receipt or order confirmation if you have one.
  3. Do not try to grind off, tape over or otherwise work around a sharp part — you cannot restore the guard the design is missing.
  4. Keep it away from children, and from anyone else in the household who might pick it up without knowing.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.

Company contact: Medtronic Perfusion Systems — 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic Perfusion Systems medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 20763000135700, 00763000135706; lot code 0232612916 0232709001 — 3, 621 units; model number 78222 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and unplug it, or take the battery out if it is cordless.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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