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# Merit Medical Class 1 Recall of Sheath Introducer
- URL: https://www.fdaweb.com/merit-medical-class-1-recall-of-sheath-introducer/
- Published: 2017-03-30T12:00:00.000Z
- Updated: 2026-09-14T22:15:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138343

Merit Medical has begun a Class 1 recall of its Prelude Short Sheath Introducer, which is used to guide the placement of catheters, grafts, and other medical devices into the veins and arteries. The recall is related to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure, an agency [recall notice ](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm549795.htm?ref=fdaweb.com)says. “If this occurs, the tip could enter the patient’s bloodstream,” it says. Affected devices were manufactured 11/23-30/2016.