Medical device recalls High risk

Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

Recall date
August 6, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2481-2025
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 12110 LV VENT 10FR, Model Number 12110

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