Merit Medical Recalls PreludeSYNC Radial Compression Devices Due to Balloon Defects

Plain-English summary

Merit Medical Systems, Inc. is recalling 1,932 units of PreludeSYNC DISTAL Radial Compression Devices, specifically models SDRB-REG-LT and SDRB-REG-RT. The recall involves specific lots identified by UDI codes H1559517, H1727668, H1666548, and H1723973.

The recall was initiated because some inflatable balloons on the devices may break or burst during the sterilization process. This defect can result in air leakage, preventing the device from maintaining the necessary pressure or compression. Consequently, this may lead to a lack of hemostasis, resulting in bleeding or a delay in treatment. The source text notes that the defect is likely to be visually identified by the clinician before use or during inflation.

The affected devices were distributed in 31 U.S. states and the District of Columbia, as well as in 12 countries outside the United States, including Canada, the United Kingdom, and Germany. Clinicians and facilities should check their inventory for the specific lot numbers and UDI codes listed in the recall notice.

The recalled product

Product

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

Manufacturer

Merit Medical Systems, Inc.

Category

Medical Device — Cardiovascular

Hazard

• bleeding
• device-failure

Affected units

1,932

Distribution

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