medical MODERATE Updated 2026-08-05

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

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Recalled Product

EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222

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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: 20763000135700, Lot Numbers: 0232602300 0232602383 0232612916 0232680078 0232708967 0232709001 0232910880 0232910881 0232910882 0233077983 0233245850 0233245860 0233245980; UDI-DI: 00763000135706, Lot Numbers: 0232612916 0232709001

✅ 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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