Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers Recalled by Merit Medical Systems, Inc. Due to Merit Medical Systems, Inc. is voluntarily conducting a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merit Medical Systems, Inc. directly.
Affected Products
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
Quantity: 60,945 devices
Why Was This Recalled?
Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
Where Was This Sold?
US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report