basixTOUCHRecalls & reported problems across all models

We found 6 models of basixTOUCH by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jul 16, 2025 and Jul 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

3 FDA recall records name at least one of these models by its device identifier, 3 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

basixTOUCH 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, 2025Class IIOpen, 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 · Recall details · FDA record ↗

2. Aug 19, 2024Class IIOpen, 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-0072-2025 · Root cause: Packaging process control · names 5 of these models · Recall details · FDA record ↗

3. Aug 19, 2024Class IIOpen, 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-0065-2025 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported basixTOUCH problems

basixTOUCH models

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

• basixTOUCH™ 00884450621417

  Syringe, Balloon Inflation, Exempt
  2 recalls0 reports
• basixTOUCH™ 00884450621059

  Syringe, Balloon Inflation, Exempt
  1 recall1 report
• basixTOUCH™ 00884450621301

  Syringe, Balloon Inflation, Exempt
  1 recall0 reports
• basixTOUCH™ 00884450621325

  Syringe, Balloon Inflation, Exempt
  1 recall0 reports
• basixTOUCH™

  Syringe, Balloon Inflation, Exempt
  1 recall0 reports
• basixTOUCH™ 00884450627105

  Syringe, Balloon Inflation, Exempt
  1 recall0 reports

Recent basixTOUCH adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES A PIECE OF THE PLASTIC WAS BROKEN OFF AND THEREFORE STERILE BARRIER IS COMPROMISED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523252 ↗

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
• basixCOMPAK34 models · 34 reports · 2 recalls
• Flex-Neck11 models · 21 reports · 2 recalls
• HeartSpan5 models · 10 reports · 2 recalls