Reported Aug 5, 2026 · Ongoing
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial…
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
- Lot codes and dates
- UDI-DI20763000135632
- Lot Numbers
02324464290232446444023248675202326015150232601516023260152202326015860232601591023260159302326021800232798265023279835302328495830232894981023289508202329026940232902697023290269802329027000232902803023290280502329028460232985469023300992202331082510233116991023312735202333349230233334966023342669402334266950233528727
- UDI-DI00763000135638
- Lot Numbers
023244644402327983530232895082023290269702329028030232902846023298546902331273520233334923
- Amount recalled
- 21,290 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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