ICU Medical 46080-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709047518), received between Oct 12, 2021 and Oct 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2021 AND INVOLVED A CARDIAC KIT WITH 03ML FLUSH DEVICE FOR (B)(6) HOSP THAT WAS REPORTED TO HAVE A DEFECTIVE LINE AND BLOOD WAS BACKING UP WHEN THE MONITORING LINE WAS IN USE ON A PATIENT. THE NURSE NOTICED THAT THE TUBING HAD SEPARATED FROM THE SIDE OF THE ACCESS PORTS FOR BLOOD DRAWS. THE BACKFLOW WAS NOTED LESS THAN FIVE MINUTES AFTER PLACEMENT AND THE NURSE WAS AT THE PATIENT¿S BEDSIDE. WITH RESPECT TO BLEED BACK AND AN ESTIMATION OF BLOOD LOSS, THE CUSTOMER INDICATED THAT HERE WAS BLEED BACK TO THE POINT OF DETACHMENT. FURTHER, IF THE NURSE WAS NOT AT BEDSIDE, IT COULD HAVE RESULTED IN A GREAT AMOUNT OF BLOOD LOSS. THE TUBING WAS IMMEDIATELY REPLACED. THE CUSTOMER INDICATED THAT THE SEPARATION OF THE TUBING WAS FROM A BONDED CONNECTION THAT WAS NOT DESIGNED TO DETACH OR DISCONNECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12618989 ↗

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.