Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto

Recalled October 23, 2024 · FDA recall Z-0060-2025 · Merit Medical Systems

Hazard

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. · FDA Class II

Units

6,565 devices

Sold at

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.

Description

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Product

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.

Manufacturer(s)

Merit Medical Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →