—#215547

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.

FDA product code: DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea

Timeline

Recall initiated: 2025-07-25
Posted by FDA: 2025-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.