Merit Medical Systems recalled 447 units of the 10Fore Hemostasis Valve on July 25, 2025. A manufacturing issue may cause a deformed silicone quad ring, posing a risk of foreign body in the fluid pathway. This recall affects the U.S. and Canada.
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.
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
The recalled 10Fore Hemostasis Valve includes Catalog Numbers MAPTEN4, MAPTEN42, and MAPTEN452. The affected lot numbers are H3098831, H3111155, H3152503, H3155611, H3186901, H3076189, H3111156, H3152504, H3155614, H3173674, and H3111162. The product was distributed worldwide, including states such as California, Florida, Louisiana, Montana, New York, South Dakota, and Wisconsin.
The recall stems from a manufacturing defect in the silicone quad ring, which can become deformed or damaged. This poses a high risk as it may lead to a foreign body in the fluid pathway.
No specific incidents or injuries have been reported related to this recall yet. However, the potential for a foreign body in the fluid pathway is significant.
Patients and healthcare providers should stop using the 10Fore Hemostasis Valve immediately. Follow the recall instructions provided by Merit Medical Systems, Inc. Contact them for further guidance.
For more information, contact Merit Medical Systems, Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2553-2025.
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