Merit Medical Systems, Inc.: Device Recall

Recall #Z-2218-2024 · 05/22/2024

Class II: Risk

Recall Details

Recall Number
Z-2218-2024
Classification
Class II
Product Type
Device
Recalling Firm
Merit Medical Systems, Inc.
Status
Ongoing
Date Initiated
05/22/2024
Location
South Jordan, UT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
52,410 (updated 06/14/2024)

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.

Product Description

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.

Distribution Pattern

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.

Other Recalls by Merit Medical Systems, Inc.

View all recalls by Merit Medical Systems, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.