FDAMarch 11, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

merit medical systemsmeritmerit medical

UPCs

108844503636730088445036367610884450363659

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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