Use caution Medical device recall · FDA · Published March 11, 2020

Merit Medical PreludeSYNC Radial Compression Devices Recall: Balloon Burst Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1796-2020Medical device Merit Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/65664-merit-medical-preludesync-radial-compression-devices-recall-balloon-burst-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65664-merit-medical-preludesync-radial-compression-devices-recall-balloon-burst-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1796-2020

Cite this page

“Merit Medical PreludeSYNC Radial Compression Devices Recall: Balloon Burst Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65664-merit-medical-preludesync-radial-compression-devices-recall-balloon-burst-risk. Based on FDA recall #Z-1796-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1796-2020%22&limit=1).

Merit Medical Systems, Inc. recalled PreludeSYNC DISTAL Radial Compression Devices due to potential balloon bursting during sterilization, the FDA said on March 11, 2020. The defect may cause air leakage and an inability to maintain pressure.

How to tell if you have it

Brand: Merit Medical
Product: PreludeSYNC DISTAL Radial Compression Devices
Model SDRB-REG-LT, Lot H1559517 (UDI 10884450363673)
Model SDRB-REG-LT, Lot H1727668 (UDI 00884450363676)
Model SDRB-REG-RT, Lot H1666548 (UDI 10884450363659)
Model SDRB-REG-RT, Lot H1723973 (UDI 10884450363659)

The hazard

Some inflatable balloons may break or burst during sterilization, resulting in air leakage and the inability to maintain pressure. This may lead to a lack of hemostasis, causing bleeding or a delay in treatment.

Context

GovInfoNow's records show Merit Medical Systems, Inc. has had 37 other recalls on record since 2006-02-24. Other recent recalls include the Embosphere 500-700 Micrometer Syringe Recall (2026-08-10), the Merit Medical Splashwire Hydrophilic Guide Wire Recall (2026-05-08), and the Philips Bridge Prep Kit Recall (2026-04-02). Other recent recalls of similar products include the Microvention Bobby Balloon Guide Catheter Recall (2026-04-30), the Diversatek Viper 3-Stage Balloon Dilator Recall (2026-03-18), and the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (2026-08-20).

How to tell if you have this one

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.

Brand
Merit Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify if your device is SDRB-REG-LT or SDRB-REG-RT.
Verify Lot Numbers
Confirm your device's lot numbers match the affected ones listed: H1559517, H1727668 for SDRB-REG-LT and H1666548, H1723973 for SDRB-REG-RT.

Where it went and when

Where it was distributed

Distributed in 32 states and D.C., and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Mar 11, 2020Firm started the recall
Apr 24, 2020FDA classified it Class II
May 6, 2020Published in FDA’s Enforcement Report
Mar 2, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/65664-merit-medical-preludesync-radial-compression-devices-recall-balloon-burst-risk">Merit Medical PreludeSYNC Radial Compression Devices Recall: Balloon Burst Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1796-2020 (March 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1796-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.