Medtronic HVAD Recall Given High-Risk Class I Designation
Executive Summary
A welding defect may allow moisture to enter affected heart pumps, which can lead to device failure, the US FDA explained. Medtronic first announced the recall in April.
Topics
- Subjects
- Recalls
- FDA
- Regulation
- Regions
- North America
- Industries
- Medical Device
- Device Areas
- Cardiology
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