DiamondTOUCHRecalls & reported problems across all models

We found 4 models of DiamondTOUCH by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

DiamondTOUCH 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. Aug 4, 2025Open, Classified

   Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

   Z-0533-2026 · Root cause: Process change control · names 2 of these models · Recall details · FDA record ↗

2. Aug 19, 2024Open, Classified

   Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

   Z-0066-2025 · Root cause: Packaging process control · names 2 of these models · Recall details · FDA record ↗

DiamondTOUCH models

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

• DiamondTOUCH™

  Syringe, balloon inflation
  1 recall0 reports
• DiamondTOUCH™ 00884450409640

  Injector and syringe, angiographic
  1 recall0 reports
• DiamondTOUCH™ 00884450409657

  Injector and syringe, angiographic
  1 recall0 reports
• DiamondTOUCH™ 00884450413463

  Injector and syringe, angiographic
  1 recall0 reports

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