PreludeSYNC DISTAL Radial Compression Devices — Class II medical device recall Z-1796-2020

Terminated recall by Merit Medical Systems, Inc., reported 2020-05-06, distributed in AL, AR, AZ, CA, CO, DC, DE, FL…. During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, wh

Recall number	`Z-1796-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Merit Medical Systems, Inc., South Jordan, UT, United States
Recall initiated	2020-03-11
Classified	2020-04-24
Reported by FDA	2020-05-06
Terminated	2022-03-02
Distributed	AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, WI
Countries outside the US	AE, CA, CH, DE, ES, FR, GB, HK, IT, JP, MX, PT, SG
Quantity	1,932
Reason classes	packaging, device malfunction
UPC / GTIN / UDI-DI	`00884450363676`, `10884450363659`, `10884450363673`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1796-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.