basixCOMPAK™ 00884450638385Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450638385), received between May 7, 2025 and Sep 17, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Aug 4, 2025Open, Classified

   Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

   Z-0533-2026 · Root cause: Process change control · 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.

• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810344 ↗
• MalfunctionJul 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25824876 ↗
• MalfunctionMay 20, 2025Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  THE ACCOUNT ALLEGES THAT DURING USE THE INFLATION DEVICE FELL APART. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055293 ↗
• MalfunctionMay 7, 2025Gas/Air Leak; Gas/Air Leak

  THE ACCOUNT ALLEGES THAT THE DEVICE DID NOT KEEP PRESSURE DURING THE CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976253 ↗