basixCOMPAK™ 00884450638323Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450638323), received between Jul 18, 2023 and May 14, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Material Separation

  THE HANDLE DETACHED DURING USE ON A PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176243 ↗
• MalfunctionDec 3, 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 CORONARY ANGIOPLASTY, JUST AFTER INSERTING A STENT, THE INFLATOR BODY AND PLUNGER BECAME DETACHED WHILE DEFLATING. HOWEVER, THE STENT BALLOON DID NOT MOVE. THE PHYSICIAN UNCOUPLED THE INFLATOR, REINSERTED THE PLUNGER, SCREWED IT BACK ON AND TIGHTENED IT SECURELY, PURGED THE AIR, RECOUPLED IT, AND WAS ABLE TO DEFLATE THE STENT BALLOON WITHOUT INCIDENT FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707712 ↗
• InjuryJul 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT A HEMOSTASIS VALVE THAT IS PACKAGED WITH THE INFLATION DEVICE KIT DETACHED DURING CONTRAST INJECTIONS. THE PHYSICIAN DECIDED TO EXCHANGE THE HEMOSTASIS DEVICE RATHER THAN POP THE VALVE BACK ON AND CONTINUE THE CASE. USUAL PRESSURES WERE USED THROUGH HEMOSTASIS DEVICE VIA THE ACIST INJECTION DEVICE DURING DEPLOYMENT WITHIN THE LEFT CORONARY NETWORK. DURING THE REPLACEMENT OF THE HEMOSTASIS VALVE, THE GUIDE CATHETER VIA GUIDEWIRE WAS REINSERTED INTO THE PATIENT RESULTING IN A PERFORATION OF A CORONARY ARTERY THAT LED TO REQUIRED MEDICAL INTERVENTION DUE TO THE PATIENTS CAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347804 ↗
• InjuryJul 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT A HEMOSTASIS VALVE THAT IS PACKAGED WITH THE INFLATION DEVICE KIT DETACHED DURING CONTRAST INJECTIONS. THE PHYSICIAN DECIDED TO EXCHANGE THE HEMOSTASIS DEVICE RATHER THAN POP THE VALVE BACK ON AND CONTINUE THE CASE. USUAL PRESSURES WERE USED THROUGH HEMOSTASIS DEVICE VIA THE ACIST INJECTION DEVICE DURING DEPLOYMENT WITHIN THE LEFT CORONARY NETWORK. DURING THE REPLACEMENT OF THE HEMOSTASIS VALVE, THE GUIDE CATHETER VIA GUIDEWIRE WAS REINSERTED INTO THE PATIENT RESULTING IN A PERFORATION OF A CORONARY ARTERY THAT LED TO REQUIRED MEDICAL INTERVENTION DUE TO THE PATIENTS CAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347418 ↗