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.
What this means for you
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
- incorrect-labeling
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.
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