Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers
Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
What this means for you
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: The recall involves a medical device with a functional defect (intermittent failure of the splittable hub) which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers. The recall involves 60,945 devices with various catalog numbers, including PLS-1007, PLS-1008, and PLS-1009.
The reason for the recall is an intermittent failure of the splittable hub. The affected devices were distributed in the US, Australia, the EU, Serbia, Israel, Malaysia, South Africa, and Bahrain. Specific lot numbers are listed in the official recall documentation.
Healthcare providers and facilities should check their inventory for the affected catalog numbers and lot numbers. Users should stop using the affected devices and contact Merit Medical Systems for instructions on how to return or dispose of them.
The recalled product
- Product
- 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-1
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Introducers
- Hazard
- Affected units
- 60,945
Distribution
Distribution scope not specified by the agency.
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