Quick Facts at a Glance
- Recall Date
- July 25, 2025
- Hazard Level
- HIGH
- Brand
- Merit Medical Systems
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Merit Medical Systems
- Product type
- Hemostasis Valve
- Model numbers
- MAPTEN4, MAPTEN42, MAPTEN452
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 25, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The 10Fore Hemostasis Valve is designed to maintain hemostasis during the introduction and withdrawal of diagnostic and interventional medical devices. Healthcare providers use it in various procedures to control blood flow and minimize complications.
Why This Is Dangerous
A deformation in the silicone quad ring affects the valve's ability to function properly. This alteration can lead to the entry of foreign bodies into the fluid pathway, presenting significant risks during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses serious health risks to patients using the affected valves during medical procedures, potentially leading to complications that require medical intervention.
Practical Guidance
How to identify if yours is affected
- Check the catalog number on the device.
- Look for the UDI-DI code on packaging or labeling.
- Inspect for the model numbers MAPTEN4, MAPTEN42, or MAPTEN452.
Where to find product info
Locate the catalog number and UDI-DI code on the packaging or directly on the hemostasis valve.
What timeline to expect
Realistic refund processing timeline is 4-6 weeks.
If the manufacturer is unresponsive
- Contact Merit Medical Systems again to escalate your request.
- Document all communications for your records.
- Consider reaching out to appropriate consumer protection agencies.
How to prevent similar issues
- When purchasing medical devices, check for FDA approval and recalls.
- Ask healthcare providers about alternative products with a proven safety record.
- Research companies' history concerning product recalls and safety issues.
Documentation advice
Keep records of your purchase, any correspondence related to the recall, and documentation of any symptoms experienced after the use of the device.
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Product Details
Catalog Numbers: MAPTEN4, MAPTEN42, MAPTEN452. UDI-DI Codes: 00884450821305, 00884450832509, 00884450821329. Sold Worldwide, including CA, FL, LA, MT, NY, SD, WI, Canada, and Korea. Quantity: 447.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Catalog Numbers: MAPTEN4, MAPTEN42, MAPTEN452
- Manufacturing defect may cause foreign body in fluid pathway
- Sold in CA, FL, LA, MT, NY, SD, WI, Canada, Korea
- Stop using the device immediately and contact the manufacturer
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Safety Guide
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