The Recall Desk
HighFDA (Devices)·Z-2806-2026·Announced 2026-08-05

Arterial Cannula Recall: Medtronic EOPA Blunt 22FR May Leak During Bypass

Medtronic recalls 21,290 EOPA arterial cannulas (BLUNT 22FR) because pinhole leaks may occur during bypass, risking 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: This is an FDA Class II recall of a medical device with potential for serious complications, but the source text does not report any injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are High.

Plain-English summary

Medtronic Perfusion Systems is recalling the EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR (Model Number 77422), an arterial return cannula used during cardiopulmonary bypass. The recall covers 21,290 units distributed worldwide, including nationwide in the U.S. Affected devices are identified by the lot numbers and UDI-DI codes listed in the FDA recall notice.

The recall was issued because pinhole leaks may occur in the wire-wound body of the cannula during cardiopulmonary bypass. If a leak occurs, potential risks include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.

Patients undergoing cardiopulmonary bypass with an affected cannula could be exposed to these risks. The FDA has classified this as a Class II recall. The source notice does not report any specific injuries or deaths.

Healthcare providers should verify whether their inventory includes the listed lot numbers and follow the instructions provided in the recall notice and by Medtronic Perfusion Systems.

The recalled product

Product
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass Cannula
Hazard
Affected units
21,290

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 (2)

  • UDI-DI: 20763000135632
  • UDI-DI: 00763000135638

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · pinhole leak

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