PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Check against the official notice below — it lists the full affected range.
Merit Medical Systems, Inc. is recalling PreludeSYNC DISTAL Radial Compression Devices (models SDRB-REG-LT and SDRB-REG-RT) because some of the inflatable balloons may break or burst during sterilization. This defect can cause air leakage and prevent the device from maintaining proper pressure and compression. As a result, patients may experience bleeding or experience delays in treatment due to lack of hemostasis (inability to stop bleeding).
The recall affects 1,932 devices distributed across the United States and multiple countries including Canada, Mexico, the United Kingdom, Switzerland, and others. The defect is likely to be identified by clinicians either through visual inspection before use or when attempting to inflate the balloon. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: U.S.: NV, IL, VA, PA, CA, AR, MA, GA, OH, NJ, TX, FL, NC, SC, MI, NH, CO, AL, MN, KS, NM, AZ, ID, MD, NY, OR, DC, DE, MO, IN, WI, IA, TN. O.U.S.: Switzerland, Hong Kong, Spain, Portugal, Canada, Singapore, United Arab Emirates, Mexico, United Kingdom, France, Japan, Germany, Italy Quantity: 1932 Lot/code info: SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676). SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.