Reported Sep 17, 2025 · Ongoing
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- 10Fore Hemostasis
- Valve Catalog Number / UDI-DI codeMAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 00884450832509Lot Numbers: H3098831 H3111155 H3152503 H3155611 H3186901 MAPTEN42 / 00884450832509 2 00884450821329Lot Numbers: H3076189 H3111156 H3152504 H3155614 H3173674 MAPTEN452 / 00884450821329 3 Lot Number: H3111162 - Amount recalled
- 447
Where it was sold
Why it was recalled
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
This product could cause temporary or reversible health problems — stop using it.
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