FDA Medical devices recall ·
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) recall
- Recall number
- Z-0985-2025
- Date
- (initiated December 12, 2024)
- Company / brand
- Medtronic Perfusion Systems
7611 Northland Dr N, Brooklyn Park, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 930 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Why was it recalled?
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0985-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.