basixCOMPAK™ 00884450638354Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of basixCOMPAK (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450638354), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
Recalls naming this device
- Dec 4, 2025Open, Classified
Inflation device handle may detach from the syringe during procedure.
Z-1123-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Mechanical Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement
THE ACCOUNT ALLEGES THAT UPON INSERTING A STENT, THE RING ON THE INFLATOR BODY BECAME UNSCREWED, CAUSING A DELAY IN THE DEFLATION OF THE STENT BALLOON. AFTER TIGHTENING THE RING, THE BALLOON DEFLATED SUCCESSFULLY. URGENT REPLACEMENT OF THE INFLATOR TO CONTINUE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909986 ↗
Other Syringe, Balloon Inflation, Exempt devices
- basixCOMPAK™ 00884450638385Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls4 reports
- basixTOUCH™ 00884450621417Merit Medical Systems, Inc. · Syringe, Balloon Inflation, Exempt2 recalls0 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
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 · each report above links to its original FDA record
- 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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