The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1796-2020·Announced 2020-05-06

Merit Medical Recalls PreludeSYNC Radial Compression Devices Due to Balloon Defects

Merit Medical Systems is recalling PreludeSYNC Radial Compression Devices because inflatable balloons may break, causing air leakage and potential bleeding.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (bleeding/lack of hemostasis) where injury has not yet been reported, fitting the High severity criteria.

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
Affected units
1,932

Distribution

Distributed in 33 states:

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