basixTOUCH™ 00884450621417Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of basixTOUCH (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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 · Recall details · FDA record ↗
- 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-0072-2025 · Root cause: Packaging process control · Recall details · FDA record ↗
Other Syringe, Balloon Inflation, Exempt devices
- basixCOMPAK™ 00884450638385Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls4 reports
- basixCOMPAK™ 00884450638521Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls0 reports
- basixCOMPAK™ TMerit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls0 reports
- basixSKY™ Initial ReleaseMerit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls0 reports
- Encore 26 M00566670Boston Scientific Corporation · Syringe, Balloon Inflation, Exempt1 recall26 reports
- basixCOMPAK™ 00884450637524Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt1 recall15 reports
- Encore 26 M0067101140Boston Scientific Corporation · Syringe, Balloon Inflation, Exempt1 recall8 reports
- basixCOMPAK™ 00884450638347Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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