Merit Medical Systems, Inc.: Prelude Guide Sheath Roadster Recalled for Incorrect Dilator Component

Agency Publication Date: May 20, 2024

Summary

Merit Medical Systems, Inc. is recalling 45 units of the Prelude Guide Sheath Roadster because some packages may contain a .038 dilator instead of the .018 dilator labeled on the product. This packaging error affects two specific models (5F and 6F sizes) distributed worldwide, including in California. Consumers who have these devices should contact their healthcare provider or the manufacturer immediately for instructions, as using the wrong dilator size can lead to serious medical complications during surgical procedures.

Risk

The use of a larger .038 dilator when a .018 dilator is expected can cause difficulty during insertion or potential vascular injury to the patient. This mismatch between the labeled size and the actual component may lead to procedure delays or physical harm if the device is forced into a space intended for a smaller dilator.

What You Should Do

Identify if you have the affected Prelude Guide Sheath Roadster by checking the package for REF PG5F45S018 (5F size) with Lot # H2800643 and UDI 00884450770757.
Check your inventory for the larger Prelude Guide Sheath Roadster REF PG6F45S018 (6F size) with Lot # H2817178 and UDI 00884450770771.
Immediately stop using any devices identified with these specific lot numbers and set them aside to ensure they are not used in clinical procedures.
Contact Merit Medical Systems, Inc. at their headquarters in South Jordan, Utah, or via their website to report possession of these units and to receive instructions on returning the product.
Healthcare providers should consult with the manufacturer regarding the appropriate clinical follow-up for any patients where this device may have been used.
For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Exchange

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Prelude Guide Sheath Roadster, 5F 0.076 (1.9 mm), 45 cm

Model / REF:

PG5F45S018

UPC Codes:

00884450770757

Lot Numbers:

H2800643

Product: Prelude Guide Sheath Roadster, 6F 0.087" (2.2 mm), 45 cm

Model / REF:

PG6F45S018

UPC Codes:

00884450770771

Lot Numbers:

H2817178

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94304

Status: Active

Manufacturer: Merit Medical Systems, Inc.

Sold By: Medical distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 2 products (18 units; 27 units)

Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if you have the affected Prelude Guide Sheath Roadster by checking the package for REF PG5F45S018 (5F size) with Lot # H2800643 and UDI 00884450770757.

Check your inventory for the larger Prelude Guide Sheath Roadster REF PG6F45S018 (6F size) with Lot # H2817178 and UDI 00884450770771.

Immediately stop using any devices identified with these specific lot numbers and set them aside to ensure they are not used in clinical procedures.

Contact Merit Medical Systems, Inc. at their headquarters in South Jordan, Utah, or via their website to report possession of these units and to receive instructions on returning the product.

Healthcare providers should consult with the manufacturer regarding the appropriate clinical follow-up for any patients where this device may have been used.

For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.