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.
Recall
- Recall Number
- Z-2553-2025
- Event Number
- 97420
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- DTL
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- July 25, 2025
- Posted
- September 11, 2025
- Address
- 1600 W Merit Pkwy South, Jordan, UT, 84095-2416
Description
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.
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.
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 [email protected] 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 [email protected] or via phone at +1 800 356 3748 | Hours: 6 am to 6 pm MST | Mon-Fri.
Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea
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