CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large recalled
Merit Medical Systems is recalling Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal, distributed nationwide in the US. The recall was initiated on 30 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0061-2025
- FDA event ID
- 95330
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Aug 2024
- FDA classified
- 11 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 30 Aug 2024 | Recall initiated by company | |
| 11 Oct 2024 | Classified by FDA | +42 days |
| 23 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 95330This product is part of a recall event; the main page for the event is Melrose Wakefield Hospital recalled by Merit Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Melrose Wakefield Hospital recalled by Merit Medical Systems | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device 30 atm/bar recalled by Merit Medical Systems | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis recalled | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis recalled | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device MAP 112 Access-9 Large Bore recalled | Merit Medical Systems | Sterility | Nationwide |
More recalls from Merit Medical Systems
All 144| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Splashwire Hydrophilic Guide Wire recalled by Merit Medical Systems | Merit Medical Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
| Device | CLASS I | DuraMax Chronic Hemodialysis Catheter recalled by Merit Medical Systems | Merit Medical Systems | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |