basixCOMPAK™ 00884450498538Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450498538), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Inflation Problem; Separation Failure; Detachment of Device or Device Component; Inflation Problem; Separation Failure; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, VASCULAR DILATION WAS PERFORMED USING A KANEKA PTA BALLOON. THE BALLOON WAS PRESSURIZED TO 30 ATM ON TWO OCCASIONS WITHOUT ISSUE. DURING THE THIRD PRESSURIZATION, A POPPING SOUND WAS REPORTED, AND THE PRESSURE GAUGE READING DROPPED TO 0 ATM. THE PLUNGER REMAINED ENGAGED AND DID NOT RETRACT. THE OPERATOR THEN DEPRESSURIZED THE DEVICE BY GRASPING THE LOCK/RELEASE BAR AND PULLING THE PLUNGER HANDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON OF THE SAME PART NUMBER AND LOT. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791676 ↗