Prelude Roadster recallZ-1875-2024 · Merit Medical Systems, Inc. · initiated Mar 14, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
FDA root cause category: Employee error
What the company is doing
On March 18, 2024 Merit Medical issued a "Urgent Medical Device Recall Notice to affected consignees via E-Mail. Merit Medical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within 7 days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Recall details
- Recall number
- Z-1875-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 14, 2024
- Posted by the FDA
- May 20, 2024
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 27 units
- Product code
- DYB
- FDA submissions
- K211405
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
Product description
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Code information (models, lots, serial numbers)
Lot # H2817178/ UDI: 00884450770771
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Prelude Roadster™ 00884450770771Merit Medical Systems, Inc. · Introducer, catheter2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94304).
- Z-1874-2024 · Open, ClassifiedPrelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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