HIGH

Merit Medical 10Fore Hemostasis Valve Recalled Due to Foreign Body Risk

Merit Medical Systems recalled 447 10Fore Hemostasis Valves following a manufacturing defect that may cause foreign bodies in the fluid pathway. The silicone quad ring may be deformed or damaged during use, posing serious health risks. Patients and providers should stop using the device immediately and follow recall instructions.

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

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

  1. Check the catalog number on the device.
  2. Look for the UDI-DI code on packaging or labeling.
  3. 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.

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

  • 447 units recalled
  • 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
View Original Recall on FDA - Medical Devices

Browse More Recalls

More from FDA_DEVICEHealth & Personal CareMedical Devices

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeHemostasis Valve
Sold At
Multiple Retailers

Product Details

Model Numbers
MAPTEN4
MAPTEN42
MAPTEN452
Affected States
ALL
Report Date
September 17, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Merit Medical CentrosFLO Hemodialysis Catheters Recalled for 35,591 Units (2026)

Merit Medical Systems has issued an active recall affecting 35,591 CentrosFLO Hemodialysis Catheters sold worldwide. The recall centers on a 16F dual-valved splittable sheath introducer that may fail to split as intended. This failure can cause hemorrhage, foreign-body retention, and procedure delays. Healthcare providers should stop using the device and follow Merit Medical's recall instructions.

Merit Medical Systems
16F dual-valved
Read more
Health & Personal Care
HIGH

Merit Medical 16F Dual-Valved Splittable Sheath Introducer Recalled for 368,264 Units Worldwide (202

Merit Medical Systems recalls 368,264 units of the 16F Dual-Valved Splittable Sheath Introducer bulk non-sterile sold worldwide. A design defect may prevent the sheath from splitting as intended, risking hemorrhage and foreign bodies. Healthcare providers should stop using the device and contact Merit Medical for instructions.

Merit Medical Systems
16F dual-valved
Read more
Health & Personal Care
HIGH

Merit Medical ProGuide 16F Dialysis Sheath Introducer Recalled Worldwide in 2026 (131 Units)

Merit Medical Systems recalled 131 units of the ProGuide chronic dialysis catheter introducer worldwide after a design defect could prevent the device from splitting as intended. The defect may cause hemorrhage, retained foreign bodies, and delays to procedures. Healthcare providers should stop using the device and follow the manufacturer’s recall instructions.

Merit Medical Systems
16F dual-valved
Read more
Health & Personal Care
HIGH

Merit Medical BioFlo DuraMax Catheter Recall 2026: 47,153 Units Worldwide

Merit Medical Systems recalled 47,153 BioFlo DuraMax Catheters distributed worldwide through medical distributors after a design defect in the 16F dual-valved splittable sheath introducer may fail to split as intended. The defect can cause hemorrhage, foreign bodies, and delays in procedures. Clinicians and patients should stop using the device immediately and follow recall instructions from Merit

Merit Medical Systems
16F dual-valved
Read more
Health & Personal Care
HIGH

Merit Medical Recalls Inflation Device Due to Detachment Hazard

Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.

Merit Medical Systems
Inflation device
Read more
Health & Personal Care
HIGH

Merit Medical Recalls Custom Manifold Kit Due to Detachment Risk

Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.

Merit Medical Systems
Inflation device
Read more
Health & Personal Care
HIGH

Merit Medical Recalls Vascular Tray Over Detaching Handle Hazard

Merit Medical Systems recalled 864 units of its Custom Waste Management Kit Vascular Tray on December 4, 2025. The handle of the inflation device may detach from the syringe during use, posing a serious risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.

Merit Medical Systems
Inflation device
Read more