Medtronic Recalls EOPA Arterial Cannula Models for Labeling Errors
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with labeling defects. Arterial cannulae are risk-of-harm products where incorrect labeling could result in patient injury during use. No illnesses or injuries have been reported, but the potential for serious harm from labeling inaccuracies on critical medical devices justifies a High severity classification.
Plain-English summary
Medtronic Perfusion Systems is recalling the EOPA Arterial Cannula, model numbers 77418 (18 Fr) and 77422 (22 Fr), due to incorrect labeling found in seven manufacturing lots. Approximately 930 units have been distributed worldwide, including throughout the United States.
The affected lot numbers are: model 77418 lot 2022041038 and model 77422 lot 2023020934. Customers who have received these devices should verify any in-stock inventory against the affected lot numbers.
Healthcare facilities and medical personnel are advised to contact Medtronic Perfusion Systems for guidance regarding device management, replacement, or return procedures.
The recalled product
- Product
- EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device
- Hazard
- Affected units
- 930
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 (4)
- Model 77418 UDI-DI: 20763000135618
- Lot Numbers: 2022041038
- Model 77422 UDI-DI: 20643169485970
- Lot Number: 2023020934
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
Same hazard · incorrect labeling
See all →- ModerateNissan Recalls Spare Tire Kits with Incorrect Placard Information
NHTSA · 2026-10-21
- High
- Moderate2022 Nissan Armada and Infiniti QX vehicles with incorrect GAWR label
NHTSA · 2026-07-15
- High
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
Similar recalls
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- ModerateMedtronic DLP Vessel Cannula Recalled for Incorrect Labeling
FDA (Devices) · 2024-03-27
- ModerateMedtronic EOPA Arterial Cannula Recalled for Missing Guidewire
FDA (Devices) · 2015-08-26
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recall: Medtronic EOPA Blunt 22FR May Leak During Bypass
FDA (Devices) · 2026-08-05