Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prelude SNAP Splittable Sheath Introducer Recalled by Merit Medical Systems, Inc. Due to There is a potential that 7F sheaths are...
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
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Quantity: 760 UNITS
Why Was This Recalled?
There is a potential that 7F sheaths are packaged as 10F sheaths.
Where Was This Sold?
This product was distributed to 29 states: AL, AR, CA, CO, DE, FL, GA, HI, IL, IA, KY, ME, MD, MA, MI, MN, NE, NV, NJ, NY, NC, OH, OR, PA, RI, TX, VT, VA, WI
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