Merit Medical recalls PreludeSYNC DISTAL Radial Compression Devices (SDRB-REG-LT/RT) due to risk of balloon burst during sterilization causing bleeding or treatment delays. Affected units have specific lot numbers.
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.
Merit Medical is recalling certain radial compression devices because they can burst during sterilization, potentially causing bleeding or delaying treatment. The defect is likely visible to clinicians before use or during inflation.
During sterilization, the inflatable balloons in these devices can break or burst, leading to air leakage. This causes the device to fail to maintain pressure, which may result in bleeding or delayed treatment. Clinicians typically identify the issue before use or during inflation.
Healthcare professionals using these devices for radial compression procedures are most at risk. Patients receiving treatment with affected devices may experience bleeding or delayed care.
Check for model numbers SDRB-REG-LT or SDRB-REG-RT. Affected units have specific lot numbers: H1559517, H1727668 for SDRB-REG-LT and H1666548, H1723973 for SDRB-REG-RT.
Identify if your device is SDRB-REG-LT or SDRB-REG-RT.
Confirm your device's lot numbers match the affected ones listed: H1559517, H1727668 for SDRB-REG-LT and H1666548, H1723973 for SDRB-REG-RT.
The devices can burst during sterilization, causing air leakage and failure to maintain pressure, which may lead to bleeding or delayed treatment.
Check for model numbers SDRB-REG-LT or SDRB-REG-RT and verify lot numbers: H1559517, H1727668 for SDRB-REG-LT and H1666548, H1723973 for SDRB-REG-RT.
No, the defect is likely visible to clinicians before use or during inflation, so they can identify and avoid affected units.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1796-2020 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1796-2020 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
