medical MODERATE Updated 2026-08-05

Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula 22FR, intended for use with cardiop

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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