Merit Medical Systems, Inc. recalls PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT

Recall date

March 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1796-2020

FDA classification

Class II

Brand / firm

Merit Medical Systems, Inc.

Sold / distributed

U.S.: NV, IL, VA, PA, CA, AR, MA, GA, OH, NJ, TX, FL, NC, SC, MI, NH, CO, AL, MN, KS, NM, AZ, ID, MD, NY, OR, DC, DE, MO, IN, WI, IA, TN. O.U.S.: Switzerland, Hong Kong, Spain, Portugal, Canada, Singapore, United Arab Emirates, Mexico, United Kingdom, France, Japan, Germany, Italy

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT