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Kangaroo 461243E (UDI 20884521706153)Recalls & reported problems

Cardinal Health, Inc. · Feeding Tube with IRIS Technology · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521706153), received between Jan 27, 2020 and Jan 27, 2020 — classified as 1 death.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Death1
  • Pneumothorax1

Recent adverse event reports

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

  • DeathJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED THAT THE CLINICIANS TRIED TO PLACE A NASOGASTRIC TUBE (NG) FOR A WHILE SO THEY COULD ADMINISTER GOLYTELY, BECAUSE THE PATIENT WASN¿T DRINKING VERY WELL. THE CUSTOMER FURTHER REPORTED THAT THEY COULDN¿T PLACE THE NASOGASTRIC TUBE BECAUSE IT WAS TOO BIG FOR THE PATIENT. THE PATIENT WAS A (B)(6)-YEAR-OLD FEMALE WITH MULTIPLE ISSUES GOING ON AND THE PATIENT HAD MEGACOLON. THE RAPID RESPONSE TEAM WAS CALLED TO PLACE A SMALLER FEEDING TUBE AND THEY PLACED THE IRIS TUBE. A STYLET WAS USED TO INSERT THE FEEDING TUBE. THE PATIENT WAS IN SUPINE POSITION WITH HEAD OF THE BED ELEVATED. THE PATIENT WAS BECOMING MORE CONFUSED, AGITATED AND SHE HAD SHORTNESS OF BREATH PRIOR TO THE FEEDING TUBE PLACEMENT. THE RESPIRATORY RATE WAS INCREASED, AND THE PATIENT HAD EXPERIENCED INCREASED SHORTNESS OF BREATH. THE PATIENT DID NOT COUGH WHILE THE TUBE WAS PLACED. THE PATIENT WAS STABLE DURING THE TUBE PLACEMENT BUT BECAME UNSTABLE LATER. THE CLINICIAN SAW BUBBLING IN THE BACK OF THE THROAT AND NEVER DID SEE TRACHEAL RINGS. THE CUSTOMER DID USE LUBRICATION BEYOND TIP OF CATHETER AND NOT ON THE TIP AND THEY DID NOT MEET RESISTANCE AND GOT TO THE 60-70 CM MARK. AN X-RAY WAS TAKEN AND FOU

    Patient problems: Death; Pneumothorax

    MAUDE report 9632635 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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