The Recall Desk
HighFDA (Devices)·Z-2808-2026·Announced 2026-08-05

Arterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass

Medtronic is recalling its EOPA arterial cannula because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, 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 with no reported hospitalizations or deaths in the source text. The hazard is a potential pinhole leak that can cause serious harm, so the rubric's High category applies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems is recalling the EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR (Model Number 77622), an arterial return cannula used during cardiopulmonary bypass. The recall covers 13,510 units distributed worldwide, including nationwide in the US. Affected lot numbers are listed in the FDA recall notice (recall number Z-2808-2026).

Pinhole leaks may occur in the wire-wound body of the cannula during cardiopulmonary bypass. The FDA notice states potential risks include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. The notice does not state that any injuries or deaths have occurred.

Users and healthcare providers should check whether their device is from an affected lot and contact Medtronic Perfusion Systems or consult the FDA recall entry for guidance. The FDA has classified this as a Class II recall.

The recalled product

Product
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass Arterial 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 (1)

  • UDI-DI: 20763000135670

Distribution

Distributed nationwide across the United States.

Related recalls

Same category