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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 11,720
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.
Part of a larger recall action
This product is one of 6 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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