basixALPHARecalls & reported problems across all models
Merit Medical Systems, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of basixALPHA 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.
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
basixALPHA 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.
- Jun 10, 2021Terminated
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Z-2166-2021 · Root cause: Device Design · names 5 of these models · Recall details · FDA record ↗
basixALPHA models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- basixALPHA™ 00884450440179Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixALPHA™ 00884450510155Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixALPHA™ 00884450511220Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixALPHA™ 00884450511305Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixALPHA™ 00884450511510Syringe, Balloon Inflation, Exempt1 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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