# FDA recall Z-0903-2022

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2022-03-01.

## Product

Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,

## Reason for recall

A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.

## Distribution

US: MN, PA, AZ, FL, IL, AK, NY, CA, TX, KY, WI, NC, NJ, VA, CO, IN, AR, MO, LA, OR, MT, MA, MI, NE, WV, KS, MS, HI, IA, NH, ME, AL, DC, DE, NM, OH, GA, MD, TN, UT, RI, SC, OK, WA, ID, ND, SD, NV, VT.  OUS: Poland, Germany, France, United Kingdom, Belgium, Korea, Republic of, Austria, Canada, Spain, Luxembourg, Italy, Switzerland, Czech Republic, Netherlands, Japan, Honduras, Colombia, Greece, Ireland

## Key facts

- **Recall number:** Z-0903-2022
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-01
- **Report date:** 2022-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0903-2022

## Citation

> AI Analytics. FDA recall Z-0903-2022. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0903-2022. Source: US FDA. Licensed CC0.

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