FDAHealthOctober 20, 2025

Medtronic Perfusion Systems — Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

⚠️ Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: October 20, 2025

US Nationwide distribution in the states of Hawaii and New York.

What's affected?

Product: Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Brand: Medtronic Perfusion Systems
Lot code: 232135734

Additional details

UDI/DI 20763000433844, Lot Number 232135734

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3850 units.

View original FDA notice →

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