Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 In
Summary
The FDA issued a Class II for Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Inse 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-0058-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 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: IN2230/B UDI-DI code: 00884450298039 Lot Number: H2287420 H2292343 H2298614 H2305033 H2309342 H2312490 H2320981 H2326309 H2331538 H2337132 H2343845 H2348707 H2353507 H2360151 H2379871 H2385818 H2395792 H2398304 H2413090 H2416387 H2421986 H2432426 H2435878 H2442961 H2446109 H2453675 H2457933 H2458274 H2466447 H2474177 H2478393 H2483314 H2486956 H2492840 H2497955 H2503844 H2507119 H2511930 H2517517 H2522877 H2528486 H2540011 H2545410 H2550516 H2554634 H2560206 H2564557 H2568221 H2574048 H2579553 H2584200 H2589842 H2594940 H2599814 H2604238 H2610524 H2614052 H2618903 H2622808 H2629605 H2633298 H2639295 H2645646 H2649893 H2655505 H2660061 H2664662 H2669779 H2673553 H2675990 H2683251 H2701290 H2709357 H2713928 H2733074 H2739475 H2746858 H2751186 H2760546 H2765638 H2789805 H2819396
Quantity Affected: 41,411 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-0058-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29