basixCOMPAK™ T (REF IN4130)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450860953), received between May 20, 2025 and Dec 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Inflation Problem1
- Mechanical Problem1
- Separation Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Inflation Problem; Detachment of Device or Device Component; Separation Problem; Inflation Problem; Detachment of Device or Device Component; Separation Problem
THE ACCOUNT ALLEGES THAT DURING THE PROCESS OF INFLATION, THE HANDLE WAS FOUND TO DETACH AND BECAME DISCONNECTED FROM THE DEVICE. THE DEVICE WAS REASSEMBLED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810385 ↗MalfunctionMay 20, 2025Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement
THE ACCOUNT ALLEGES THAT UPON INFLATING AND DEFLATING THE STENOSIS WITHIN THE PATIENT WITH THE DEVICE, THE ENTIRE PLUNGER CAME OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055282 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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