10Fore Hemostasis Valve recall: Foreign Material
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore…
Why was 10Fore Hemostasis Valve 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 Lot Numbers: H3098831 H3111155 H3152503 H3155611 H3186901 MAPTEN42 / 00884450832509 Lot Numbers: H3076189 H3111156 H3152504 H3155614 H3173674 MAPTEN452 / 00884450821329 Lot Number: H3111162
- Product
- 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 447
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea
- Recall date
- September 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)