basixCOMPAK™ 00884450016756Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450016756), received between Feb 6, 2020 and Apr 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (1 report).
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
Most reported problems
Device problems
- Failure to Deflate1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Failure to Deflate; Failure to Deflate
THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PROCEDURE, THE INFLATION DEVICE WAS UNABLE TO DEFLATE THE BALLOON. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21891999 ↗MalfunctionFeb 6, 2020Packaging Problem; Packaging Problem
THE ACCOUNT ALLEGES THAT DURING PREPARATIONS FOR AN INTERVENTIONAL PROCEDURE A HOLE IN THE OUTER PACKAGING OF AN INFLATION DEVICE WAS IDENTIFIED. A NEW DEVICE WAS USED FOR THIS PROCEDURE. NO PATIENT INJURY TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9679234 ↗
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- Encore™ 26 M001151050Boston Scientific Corporation · Syringe, balloon inflation1 recall54 reports
- PRESTO ID4030Bard Peripheral Vascular, Inc. · Syringe, balloon inflation1 death98 reports
- Encore™ 26 Advantage Kit H74904527011Boston Scientific Corporation · Syringe, balloon inflation1 recall28 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.