Z-1796-2020Class II

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

Name: Z-1796-2020 PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Creator: Merit Medical Systems, Inc.
Published: 2020-03-11
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2020-03-11 / Terminated / root cause: sterility

FDA source

Merit Medical Systems, Inc. began a recall of PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT on 2020-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1796-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-11
Posted: 2020-04-24
Terminated: 2022-03-02
Recalling firm: Merit Medical Systems, Inc.
Product: PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Product code: DXC Clamp, Vascular
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.
Root cause tag: sterility
FDA root cause: Other
Action: On 03/11/2020, Urgent Product Recall Notices were mailed via second day service. The recalling firm requests that customers immediately stop using, quarantine, and return the affected lots. Further, they requested that customers make personnel within their organization aware of this field action. If the product was further distributed to other facilities, institutions, or manufacturers, customers were asked to ensure this notice was immediately shared with them and note the quantity distributed on the customer response form. Customers with additional questions were encouraged to call 801-208-4381.
Quantity in commerce: 1932
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
Product codes and lots: SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676). SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1796-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1796-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-24

Product code DXC

K180723Class IIPreludeSYNC DISTAL Radial Compression SystemMerit Medical Systems, Inc. / cleared 2018-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)