Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
- Recall date
- August 6, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2480-2025
- FDA classification
- Class I
- Brand / firm
- Medtronic Perfusion Systems
- Sold / distributed
- Worldwide - US Nationwide distribution.
Why it was recalled
The catheters may not retain their shape.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
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