Merit Medical Systems, Inc. PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676). SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)
Merit Medical Systems, Inc. is recalling PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT due to During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 03/11/2020, Urgent Product Recall Notices were mailed via second day service. The recalling firm requests that customers immediately stop using, quarantine, and return the affected lots. Further, they requested that customers make personnel within their organization aware of this field action. If the product was further distributed to other facilities, institutions, or manufacturers, customers were asked to ensure this notice was immediately shared with them and note the quantity distributed on the customer response form. Customers with additional questions were encouraged to call 801-208-4381.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, IA, KS, MD, MA, MI, MN, MO, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, VA, WI, DC
Page updated: Jan 10, 2026