basixCOMPAK™ 00884450544501Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of basixCOMPAK (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450544501), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 death.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT POST CARDIAC CATHETERIZATION PROCEDURE ON (B)(6) 2021, THE PATIENT SUFFERED CARDIAC COMPLICATIONS RESULTING IN CARDIAC ARREST AND PATIENT EXPIRATION ON THE SAME DAY. A DIAGNOSTIC GUIDEWIRE AND AN INFLATION DEVICE WERE USED DURING THE PROCEDURE. NO SPECIFIC DEVICE FAILURES HAVE BEEN COMMUNICATED ONLY VAGUE ALLEGATIONS OF VARIOUS MEDICAL DEVICES BEING UNFIT FOR USE HAVE BEEN COMMUNICATED.
Patient problems: Cardiac Arrest
MAUDE report 16187105 ↗
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
- 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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