Medtronic Perfusion Systems: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Nu
Read the official notice at FDA (device) →
Get alerts for Medtronic Perfusion Systems
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medtronic Perfusion Systems
- Product
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution.
- Recall initiated
- 2026-06-24
- Code info
- UDI-DI: 20763000135670, Lot Numbers: 0232601501 0232601510 0232601549 0232601550 0232602178 0232602290 0232602302 0232910952 0232910953 0232910954 0232910955 0233244075 0233244301 0233244531 0233286362 0233286374 0233286390 0233409034 0233416071 0233528731
- Product quantity
- 13,510 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Brooklyn Park
- State
- MN
- Country
- United States
- Event id
- 99320
Free daily digest + "My products" watchlist