Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PreludeSYNC DISTAL Radial Compression Devices Recalled by Merit Medical Systems, Inc. Due to During the sterilization of radial compression devices, some...
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
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Quantity: 1932
Why Was This Recalled?
During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.
Where Was This Sold?
This product was distributed to 33 states: AL, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, IA, KS, MD, MA, MI, MN, MO, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, VA, WI, DC
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