ICU Medical 46100-83Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619069162), received between Aug 13, 2025 and Aug 13, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K932141); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Air/Gas in Device; Air/Gas in Device

  A COMPLAINT WAS RECEIVED REGARDING A CATH LAB KIT FOR INDUSTRIAL DRUG SUPPLIES, USA, THAT EXPERIENCED AIR IN LINE DURING INFUSION RESULTING IN A CORONARY AIR EMBOLISM BUT NO INTERVENTION REQUIRED. THE REPORTER STATED THAT "THEY HAVE FAULTY MANIFOLD/SYRINGES INTRODUCING AIR IN THE SYSTEM. THE PATIENT DEVELOPED CORONARY AIR EMBOLISM BUT WAS LUCKILY STABLE." THE PROBLEM OCCURRED DURING INFUSION DURING INJECTING CORONARIES. THE TYPE OF PROCEDURE WAS CARDIAC CATHETERIZATION. THE LENGTH OF TIME THE PRODUCT WAS IN USE WAS 30 MINUTES. THERE WAS NO SERIOUS INJURY/DEATH NOR BLOOD LOSS. NO CHEMO LEAK NOR UNPROTECTED CHEMO EXPOSURE. NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE DEVICE(S) WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THE PATIENT HAD JUST PAIN AND ECG CHANGES DUE TO AIR EMBOLISM. THE STATUS OF THE PATIENT WAS RETURNED TO BASELINE CONDITION.

  Patient problems: Air Embolism

  MAUDE report 22800410 ↗
• MalfunctionAug 13, 2025Air/Gas in Device; Air/Gas in Device

  A COMPLAINT WAS RECEIVED REGARDING A CATH LAB KIT FOR INDUSTRIAL DRUG SUPPLIES, USA, THAT EXPERIENCED AIR IN LINE DURING INFUSION. THE REPORTER STATED THAT THEY HAVE FAULTY MANIFOLD/SYRINGES INTRODUCING AIR IN THE SYSTEM. THE PROBLEM OCCURRED DURING INFUSION DURING INJECTING CORONARIES. THE TYPE OF PROCEDURE WAS CARDIAC CATHETERIZATION. THE ISSUE WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. THE LENGTH OF TIME THE PRODUCT WAS IN USE WAS 30 MINUTES. THERE WAS NO SERIOUS INJURY/DEATH NOR BLOOD LOSS. NO CHEMO LEAK NOR UNPROTECTED CHEMO EXPOSURE. NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE DEVICE(S) WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932141. One submission often covers many models, so check the product and lot details in each record.

• Z-0621-05 · Nov 2, 2004 · Terminated
  Catheterization Kits containing Angiographic Syringes with rotator connector.