basixALPHA™ 00884450511220Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- 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Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.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 · FDA record ↗
Other Syringe, Balloon Inflation, Exempt devices
- basixCOMPAK™ 00884450638385Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls4 reports
- basixCOMPAK™ TMerit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls0 reports
- basixCOMPAK™ 00884450638521Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls0 reports
- basixTOUCH™ 00884450621417Merit 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.