Prelude Roadster Guide Sheath
Medical device recall Z-2218-2024. Published in FDA’s Enforcement Report on Jul 3, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 3, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- 52,410 (updated 06/14/2024) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
52,410 (updated 06/14/2024), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Code/Lot Number/UDI-DI PG4F45S H2409286 00884450531709 H2511381 00884450531709 H2532402 00884450531709 H2542733 00884450531709 H2602038 00884450531709 H2613452 00884450531709 H2655892 00884450531709 H2668983 00884450531709 H2684566…
Every code shown here, 2,000 characters
Catalog Code/Lot Number/UDI-DI PG4F45S H2409286 00884450531709 H2511381 00884450531709 H2532402 00884450531709 H2542733 00884450531709 H2602038 00884450531709 H2613452 00884450531709 H2655892 00884450531709 H2668983 00884450531709 H2684566 00884450531709 H2800559 00884450531709 H2808568 00884450531709 H2817152 00884450531709 H2830841 00884450531709 H2839229 00884450531709 H2852688 00884450531709 PG4F90S H2418703 00884450531716 H2478781 00884450531716 H2532524 00884450531716 H2542736 00884450531716 H2642436 00884450531716 H2662245 00884450531716 H2668984 00884450531716 H2684572 00884450531716 H2757247 00884450531716 H2763317 00884450531716 H2876572 00884450531716 PG5F45MP H2409290 00884450531914 H2478782 00884450531914 H2542737 00884450531914 H2633727 00884450531914 H2655894 00884450531914 H2662249 00884450531914 H2684571 00884450531914 H2722066 00884450531914 H2757249 00884450531914 H2777503 00884450531914 H2785759 00884450531914 H2821571 00884450531914 H2830842 00884450531914 PG5F45R H2418694 00884450531921 H2474337 00884450531921 H2532525 00884450531921 H2569083 00884450531921 H2684579 00884450531921 H2722072 00884450531921 H2757250 00884450531921 H2785760 00884450531921 H2800565 H2918260 PG5F45S H2412933 00884450531730 H2418701 00884450531730 H2460087 00884450531730 H2510831 00884450531730 H2542738 00884450531730 H2589671 00884450531730 H2598840 00884450531730 H2633728 00884450531730 H2652758 00884450531730 H2655895 00884450531730 H2673477 00884450531730 H2684561 00884450531730 H2748336 00884450531730 H2757252 00884450531730 H2785761 00884450531730 H2813084 00884450531730 H2821574 00884450531730 H2830844 00884450531730 H2839234 00884450531730 H2852691 00884450531730 H2862025 00884450531730 H2877519 00884450531730 H2892964 PG5F45S018 H2748630 00884450770757 H2757274 00884450770757 H2800643 00884450770757 H2830864 00884450770757 H2843966 00884450770757 PG5F90MP H2426296 00884450531952 H2478800 00884450531952 H2532526 00884450531952 H2792291 00884450531952 H2800566…
FDA’s list runs to 12,840 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
48 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 22, 2024.
- FDA classified it on Jun 27, 2024.
- FDA’s Enforcement Report published it on Jul 3, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Merit Medical Systems, Inc., of South Jordan, UT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 12,840 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.