FDA recall Z-2811-2026

Product

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

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2026-06-24

Report date

2026-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2811-2026