Merit Medical Prelude Pro Sheath Introducer Recalled for Incorrect Dilator Packaging
Merit Medical Systems is recalling Prelude Pro Sheath Introducers packaged with a 0.035-inch dilator instead of the labeled 0.038-inch size.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a packaging/labeling discrepancy regarding the dilator size, which is a moderate risk compared to direct contamination or structural failure.
Plain-English summary
Merit Medical Systems, Inc. is recalling 1,445 units of the Merit Medical Prelude Pro Sheath Introducer, 6F (2.0mm) 11cm, catalog number PR0-6F-11-038, lot number H767887. The device is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for diagnostic and therapeutic procedures.
The recall was initiated because some of the introducer sheaths were packaged with a 0.035-inch dilator rather than the labeled 0.038-inch dilator. This packaging discrepancy affects one specific lot of the sterile, ethylene oxide-sterilized devices.
The affected products were distributed worldwide, including in the United States (specifically Tennessee, Nebraska, Massachusetts, South Carolina, Wisconsin, and Utah) and internationally to Belgium, Switzerland, the United Kingdom, and Germany. Users should stop using the affected devices and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 1,445
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 (2)
- Catalo Number PR0-6F-11-038
- Lot Number H767887
Distribution
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