Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device where the defect (pinhole leaks) can lead to serious injury such as organ dysfunction or vessel perforation.
Plain-English summary
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, Model Number 77522. This device is intended for use with cardiopulmonary bypass as an arterial return cannula.
Potential pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. These leaks may lead to risks including hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
This recall affects 11,720 units distributed nationwide in the US and worldwide. Affected units include specific lot numbers for UDI-DI 00199150023288 and UDI-DI 20199150023282.
The recalled product
- Product
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- device-failure
- leakage
- organ-dysfunction
- vessel-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00199150023288
- Lot Numbers: 0233286436
- UDI-DI: 20199150023282
Distribution
Distributed nationwide across the United States.
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