medical Class II Updated 2020-05-06

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

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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

Lot/Code Info: SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676). SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)

View official government recall

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