basixCOMPAK™ 00884450637524Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00884450637524), received between May 7, 2025 and Aug 11, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211800 ↗
• MalfunctionJun 26, 2026Detachment of Device or Device Component

  CUSTOMER REPORTED THAT WHEN TRYING TO INFLATE TO THE WHITE ROTATING ARM IN THE MIDDLE, IT GOT DETACHED FROM THE TRANSPARENT BODY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635651 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  CUSTOMER REPORTED WHEN PRESSING THE MIDDLE WHITE SWING ARM UPWARD, IT DETACHED FROM THE MIDDLE TRANSPARENT BARREL. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623044 ↗
• MalfunctionMar 9, 2026Loose or Intermittent Connection; Detachment of Device or Device Component

  A CUSTOMER ALLEGED DURING USE, THE INFLATION SYRINGE UNSCREWS. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550722 ↗
• MalfunctionFeb 12, 2026Inflation 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. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327160 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  A CUSTOMER ALLEGED DURING A PROCEDURE IN THE CARDIOLOGY DEPARTMENT, THE HANDLE OF THE MERIT BASIXCOMPAK BROKE OFF. NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321743 ↗
• MalfunctionJan 13, 2026Inflation Problem; Detachment of Device or Device Component; Separation Problem

  THE ACCOUNT ALLEGES THAT THE RETAINER CAP OF THE INFLATION DEVICE WAS FOUND TO BE LOOSE. THIS MADE IT IMPOSSIBLE TO INFLATE THE DEVICE NORMALLY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054291 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER ALLEGED A MERIT INFLATOR HANDLE DISCONNECTED AT THE SCREW THREAD. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877224 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER ALLEGED A MERIT INFLATOR HANDLE DISCONNECTED AT THE SCREW THREAD. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877223 ↗
• 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. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810607 ↗
• MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem

  THE ACCOUNT ALLEGES THAT DURING THE PROCESS OF INFLATION, THE HANDLE WAS FOUND TO BE DAMAGED AND BECAME DISCONNECTED FROM THE DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659770 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  CUSTOMER REPORTS THE HANDLE DETACHED FROM THE DEVICE . NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624766 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  CUSTOMER REPORTS THE DEVICE SEPARATED INTO 2 PIECES ON DEFLATION. NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623570 ↗
• MalfunctionNov 10, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  THE ACCOUNT ALLEGES THAT DURING A CORONARY ANGIOPLASTY THE HANDLE OF THE INFLATION DEVICE BROKE. A PHOTO FROM THE ACCOUNT SHOWS THAT THE HANDLE DISASSEMBLED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513790 ↗
• MalfunctionMay 7, 2025Gas/Air Leak; Gas/Air Leak

  THE ACCOUNT ALLEGES THAT DURING A DURING INFLATIONS IN A PCI PROCEDURE THE OPERATOR REPORTED THAT THE INFLATION DEVICE WAS LEAKING AIR AND THE BALLOON COULD NOT BE INFLATED TO THE INTENDED ATMS. A NEW INFLATION DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976252 ↗