# FDA recall Z-2218-2024

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2024-05-22.

## Product

Prelude Roadster Guide Sheath REF:  -PG4F45S  -PG4F90S  -PG5F45MP  -PG5F45R  -PG5F45S  -PG5F45S018  -PG5F90MP  -PG5F90S  -PG5F90S018  -PG6F45HS  -PG6F45MP  -PG6F45R  -PG6F45S  -PG6F45S018  -PG6F65MP  -PG6F65S  -PG6F65SX  -PG6F90MP  -PG6F90MPX  -PG6F90SX  -PG6F90SX018  -PG7F45MP  -PG7F45MPX  -PG7F45RX  -PG7F45S  -PG7F45SX  -PG7F65SX  -PG7F90SX  -PG8F45MPX  -PG8F45S  -PG8F45SX  -PG8F65SX  -PG8F90SX  -X9PG700001    The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

## Reason for recall

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use.  This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of  Argentina, Brazil, Canada, Cayman Island, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Republic of Korea, Mexico, New Zealand, Peru, South Africa, and Uruguay.

## Key facts

- **Recall number:** Z-2218-2024
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-22
- **Report date:** 2024-07-03

- **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-2218-2024

## Citation

> AI Analytics. FDA recall Z-2218-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2218-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*