basixCOMPAK™ 00884450638347Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450638347), received between Sep 3, 2025 and Jan 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

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.

Recalls naming this device

1. 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Inflation Problem; Detachment of Device or Device Component; Separation Problem

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO DEFLATE WITH THE INFLATION DEVICE, THE HANDLE SEPARATED FROM THE REST OF THE DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199299 ↗
• MalfunctionSep 3, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE REPORTED EVENT. IT WAS REPORTED THE HANDLE OF THE INFLATION DEVICE DETACHED. THE NURSE USING THE DEVICE WAS MANIPULATING THE DEVICE WHEN THE HANDLE FELL OFF. THERE WAS NO REPORT OF THE INABILITY FOR A BALLOON TO DEFLATE FOR THIS REPORTED EVENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952884 ↗
• MalfunctionSep 3, 2025Material Separation; Detachment of Device or Device Component; Failure to Deflate; Material Separation; Detachment of Device or Device Component; Failure to Deflate

  ADDITIONAL INFORMATION WAS RECEIVED IN A MEETING ON 15OCT2025. THE FRANCE TEAM CONFIRMED THEY HAD AN INABILITY TO DEFLATE BALLOON OCCUR ON ONE UNIT DURING A CORONARY ANGIOPLASTY OF THE LEFT CORONARY TRUNK. THE HANDLE STAYED ATTACHED BUT WOULD NOT DEFLATE. THEY WERE ABLE TO USE ANOTHER INFLATOR, AND THE PATIENT SUFFERED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952880 ↗
• MalfunctionSep 3, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  OUR ANGIOGRAPHY DEPARTMENT HAS ENCOUNTERED A PROBLEM WITH THE MERIT INFLATOR REFERENCE IN4352 I3129671 (ISSUE ON 07/01/2025). THE INFLATOR HANDLE ENDED UP IN THE NURSE'S HAND. NO PATIENT DETAILS OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952877 ↗