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Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion...

FDA Device Recall #Z-0061-2025 — Class II — August 30, 2024

Recall Summary

Recall Number Z-0061-2025
Classification Class II — Moderate risk
Date Initiated August 30, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Merit Medical Systems, Inc.
Location South Jordan, UT
Product Type Devices
Quantity 51,900 devices

Product Description

Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 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.

Reason for Recall

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

Distribution Pattern

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.

Lot / Code Information

Catalog Number: IN2530/B UDI-DI code: 00884450298060 Lot Number: H2305037 H2309345 H2312492 H2320984 H2326312 H2331540 H2337135 H2343848 H2348709 H2353510 H2379875 H2385823 H2398320 H2413098 H2416393 H2421995 H2426129 H2432439 H2435893 H2443007 H2446113 H2453678 H2457937 H2458275 H2466457 H2474179 H2483316 H2486955 H2492844 H2497959 H2503846 H2507122 H2511932 H2517520 H2522881 H2528489 H2534960 H2540016 H2545413 H2550521 H2554673 H2560209 H2564559 H2568225 H2574051 H2579557 H2584204 H2594880 H2594944 H2599817 H2604242 H2610526 H2614059 H2618906 H2622811 H2629607 H2633301 H2639298 H2645654 H2649898 H2655509 H2660065 H2664666 H2669781 H2672437 H2673582 H2683311 H2688025 H2693066 H2703591 H2713947 H2733076 H2746748 H2751197 H2760547 H2769987 H2774666 H2784537 H2789807 H2793110 H2801750 H2806027 H2810778 H2824764 H2834413 H2838430 H2845204 H2847853 H2849888 H2849889 H2856554 H2861492 H2867260 H2871518 H2880698 H2890797 H2907144 H2912644 H2918429 H2925194 H2929405 H2934699 H2937986 H2943479 H2978085 H2982496 H2989541 H2994311 H3000025 H3009570

Other Recalls from Merit Medical Systems, Inc.

Recall # Classification Product Date
Z-1578-2026 Class I DuraMax Chronic Hemodialysis Catheter, REF: H78... Feb 13, 2026
Z-1576-2026 Class I ProGuide Chronic Dialysis Catheters, REF: DC014... Feb 13, 2026
Z-1577-2026 Class I 16F Dual Valved Splittable Sheath Introducer (b... Feb 13, 2026
Z-1575-2026 Class I CentrosFLO Hemodialysis Catheters, REF: CENFP15... Feb 13, 2026
Z-1579-2026 Class I BioFlo DuraMax Catheter, REF: H965103028011/A, ... Feb 13, 2026

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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