Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Recalled by Merit Medical Systems, Inc. Due to Due to a manufacturing process resulting in holes/breaches...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merit Medical Systems, Inc. directly.
Affected Products
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Quantity: 6,565 devices
Why Was This Recalled?
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report