FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch
Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves a product defect where medical device contents do not match their labeling. The mismatch represents a risk-of-harm scenario in medical procedures where incorrect component sizing could be used undetected. No injuries or illnesses have been reported, placing it within the High severity tier.
Plain-English summary
Merit Medical Systems, Inc. is recalling 18 units of the Prelude Guide Sheath Roadster medical device (REF PG5F45S018, Lot # H2800643 / UDI: 00884450770757) due to a potential labeling discrepancy. Sheaths labeled as containing .018 dilators may actually contain .038 dilators instead.
This mismatch between the label and actual contents creates a risk during medical procedures if the incorrect component size is used without detection. No injuries or illnesses have been reported to date in connection with this issue.
The affected products were distributed worldwide, including throughout the United States (with specific distribution in California), as well as in New Zealand and Canada.
Patients and healthcare providers in possession of these devices should verify the actual contents before use. Individuals with questions or concerns should contact Merit Medical Systems.
The recalled product
- Product
- Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # H2800643/ UDI: 00884450770757
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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