10Fore Hemostasis Valve (Merit Medical) – Silicone Ring Defect (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 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.
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Merit Medical Systems, Inc. is recalling 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 0088445083 due to 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 flui. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 07/23/2025, the firm emailed an "URGENT MEDICAL DEVICE RECALL NOTICE" to customers informing them that due to a manufacturing defect. Specifically, the o-ring between the y-body and the rotator may be damaged during assembly and a portion of the o-ring may remain loose or detach. Use of the affected product may result in a foreign body in the fluid path. Customer are instructed to: Immediately stop using or distributing the affected lots and return to Merit. 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at response@merit.com within 10 business days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. Any questions concerning this communication, contact your Merit Sales Representative or Merit Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748 | Hours: 6 am to 6 pm MST | Mon-Fri.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026