EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an ar… recall
Medtronic Perfusion Systems recalled EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an ar… on August 5, 2026 because of pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. It was sold nationwide.
Why it was recalled
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.
What's recalled
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Quantity: 3,110 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide - US Nationwide distribution. - Status
- Ongoing
- Recall number
- Z-2809-2026
- Source
- U.S. Food and Drug Administration
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