Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto
Summary
The FDA issued a Class II for Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion by Merit Medical Systems, Inc.. Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier..
Details
Source
Device Recall
External ID
Z-0060-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Catalog Number: IN2430/B UDI-DI code: 00884450298053 Lot Number: H2298615 H2305035 H2309343 H2320982 H2326310 H2353508 H2369554 H2385820 H2395793 H2398305 H2413092 H2416388 H2421988 H2426107 H2432428 H2435884 H2442968 H2446110 H2453676 H2457934 H2462756 H2466450 H2478394 H2486953 H2492841 H2497956 H2507120 H2517518 H2522878 H2528487 H2540012 H2545411 H2554635 H2568222 H2574049 H2579554 H2584201 H2589843 H2594941 H2599815 H2614054 H2618904 H2622809 H2633299 H2639296 H2645647 H2649894 H2655507 H2660062 H2664663 H2669780 H2673558 H2697508 H2713941 H2733075 H2746745 H2751196 H2765642 H2806015 H2815182 H2819813 H2834412 H2842698 H2849884 H2861491 H2907143 H2918428
Quantity Affected: 6,565 devices
Reason for Recall
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-30
Company
South Jordan, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Merit Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merit Medical Systems, Inc. have FDA actions?
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0060-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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