The Recall Desk
HighFDA (Devices)·Z-2811-2026·Announced 2026-08-05

Arterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass

Medtronic is recalling EOPA 3D Arterial Cannula 22FR because pinhole leaks may occur during cardiopulmonary bypass, potentially causing hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device with potential for serious injury during use; no injuries or deaths are reported in the notice, so the 'risk-of-harm products where injury has not yet been reported' criterion applies.

Plain-English summary

Medtronic Perfusion Systems is recalling the EOPA 3D Arterial Cannula 22FR (Model 78322), an arterial return cannula used during cardiopulmonary bypass. The recall covers 1,424 units distributed worldwide, including nationwide in the United States. The FDA recall notice identifies affected units by UDI-DI and lot numbers.

The device may develop pinhole leaks in its wire-wound body during cardiopulmonary bypass. Potential risks from this condition include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.

This recall affects healthcare facilities and patients who use this cannula during cardiopulmonary bypass procedures. The FDA has classified the recall as Class II. The recall notice lists affected lot numbers and UDI-DI identifiers; no specific consumer instructions are included in the notice.

The recalled product

Product
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass Cannula
Hazard
  • pinhole-leak
  • hypovolemia
  • vessel-laceration
  • ischemia

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI-DI: 20199150023251
  • Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787
  • UDI-DI: 00199150023257
  • Lot Numbers: 0232862787

Distribution

Distributed nationwide across the United States.

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