PreludeSYNCRecalls & reported problems across all models

We found 4 models of PreludeSYNC by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2025 and Sep 30, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PreludeSYNC recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 11, 2020Terminated

   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.

   Z-1796-2020 · Root cause: Other · names 2 of these models · Recall details · FDA record ↗

Most reported PreludeSYNC problems

PreludeSYNC models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PreludeSYNC™ 10884450363659

  CLAMP, VASCULAR
  1 recall0 reports
• PreludeSYNC™ 10884450363673

  CLAMP, VASCULAR
  1 recall0 reports
• PreludeSYNC™ 10884450567781

  CLAMP, VASCULAR
  3 reports
• PreludeSYNC™ 10884450286880

  CLAMP, VASCULAR
  1 report

Recent PreludeSYNC adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950763 ↗
• MalfunctionDec 15, 2025Gas/Air Leak; Gas/Air Leak

  THE ACCOUNT ALLEGES THAT DURING USE THE BALLOON OF THE RADIAL BAND LEAKED AND WAS UNUSABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810591 ↗
• MalfunctionDec 15, 2025Gas/Air Leak; Gas/Air Leak

  THE ACCOUNT ALLEGES THAT DURING USE THE BALLOON OF THE RADIAL BAND LEAKED AND WAS UNUSABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810587 ↗
• InjuryNov 26, 2025Gas/Air Leak; Gas/Air Leak

  THE ACCOUNT ALLEGES THAT DURING A RADIAL ACCESS PROCEDURE, THE PHYSICIAN TRIED TO USE TWO DIFFERENT MERIT RADIAL COMPRESSION DEVICES. AIR WAS LEAKING BACK OUT OF THE DEVICE, AND THERE WAS NOT ENOUGH PRESSURE TO CLOSE THE RADIAL ARTERY ACCESS SITE. THE PATIENT DEVELOPED A LARGE HEMATOMA AND WAS ADMITTED OVERNIGHT FOR OBSERVATION.

  Patient problems: Hematoma

  MAUDE report 23658625 ↗

Other Merit Medical Systems, Inc. products

• Aspira11 models · 36 reports · 10 recalls
• Impress145 models · 481 reports
• Monarch6 models · 37 reports · 7 recalls
• Bridge Prep Kit4 models · 6 reports · 3 recalls
• Prelude Roadster33 models · 1 reports · 3 recalls
• basixTOUCH6 models · 1 reports · 3 recalls
• basixCOMPAK34 models · 34 reports · 2 recalls
• Flex-Neck11 models · 21 reports · 2 recalls