Class II U.S. Food and Drug Administration

Medtronic Perfusion Systems EOPA 3D Arterial Cannula 22FR 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

The defect here lets a sharp component break loose or become exposed, and that is a hazard that does not improve with careful use.

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-2811-2026
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
1,424 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787
UPC codes
20199150023251, 00199150023257

Products covered by this recall

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

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.

  • 20199150023251
  • 00199150023257

Lot or batch code

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

  • 0232862787 — 1
  • 424 units

Model or item number

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

  • 78322 — 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 — The defect here lets a sharp component break loose or become exposed, and that is a hazard that does not improve with careful use.

  1. Stop using the product and unplug it, or take the battery out if it is cordless.
  2. Photograph any damage or breakage before you send the item back, because the company will often ask for it.
  3. Follow the remedy on this page and keep the receipt or order confirmation if you have one.
  4. Do not try to grind off, tape over or otherwise work around a sharp part — you cannot restore the guard the design is missing.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.

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 20199150023251, 00199150023257; lot code 0232862787 — 1, 424 units; model number 78322 — 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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