FDA recall Z-2807-2026

Product

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

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-2807-2026