# FDA recall Z-1796-2020

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2020-03-11.

## Product

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

## 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

## Key facts

- **Recall number:** Z-1796-2020
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-11
- **Report date:** 2020-05-06
- **Termination date:** 2022-03-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1796-2020

## Citation

> AI Analytics. FDA recall Z-1796-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1796-2020. Source: US FDA. Licensed CC0.

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