Merit PreludeEASE Hydrophilic Sheath Introducer Dilator Recall
Merit Medical Systems is recalling 335 PreludeEASE Hydrophilic Sheath Introducer Dilators because the tips are undersized and cannot pass a 0.021-inch guide wire.
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. The hazard is a functional defect (inability to pass a guide wire) rather than a direct safety hazard like a fracture or contamination, and no injuries are reported in the source text.
Plain-English summary
Merit Medical Systems, Inc. is recalling 335 units of the PreludeEASE Hydrophilic Sheath Introducer Dilator. The affected lots are H1014678, H1039272, H1029150, H1039269, and H1029151. These devices were distributed nationwide.
The recall is being issued because the dilator tips were manufactured with an undersized inner diameter. As a result, the dilators will not allow the passage of a 0.021-inch (0.53 mm) guide wire, which is necessary for the intended use of the device.
The PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. Users should check their inventory for the specific lot numbers listed above and stop using the affected dilators.
The recalled product
- Product
- PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 335
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 (5)
- Lots: H1014678
- H1039272
- H1029150
- H1039269
- H1029151
Distribution
Distributed nationwide across the United States.
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