Kangaroo 716170Recalls & reported problems
Cardinal Health, Inc. · Skin Level Balloon Gastrostomy Kit · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521010994), received between Mar 28, 2023 and Oct 19, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fluid/Blood Leak2
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Erythema1
- Failure to Anastomose1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
CUSTOMER REPORTS: THE SHAFT OF THE SKIN LEVEL DEVICE (SLD) WAS BROKEN, JUST PRIOR TO THE TIME THAT IT WAS DUE FOR A REGULAR CHANGE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT IN PAIN WITH A LEAKING STOMA FOR A DAY. THE SLD WAS FOUND TO BE LEAKING. THE PATIENT WAS REFERRED TO THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) CLINIC IN 4 DAYS TIME WITH SKIN BURNS AROUND THE SLD DRESSINGS.
Patient problems: Failure to Anastomose; Pain
MAUDE report 17970215 ↗MalfunctionJun 22, 2023Material Rupture; Material Rupture
THE CUSTOMER REPORTED THE TUBE WAS INSERTED ON (B)(6) 2023 AND THE BALLOON BURST 2 DAYS LATER ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181704 ↗MalfunctionApr 5, 2023Break; Break
CUSTOMER REPORTS: THE TUBE WAS INSERTED ON (B)(6) 2022 AND A BROKEN SHAFT WAS DISCOVERED ON (B)(6) 2023 RESULTING IN LOSS OF FEED AND MEDS. START OF PERISTOMAL ERYTHEMA.
Patient problems: Erythema
MAUDE report 16682608 ↗MalfunctionMar 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: THE TUBE WAS INSERTED ON (B)(6) 2022 AND THE VALVE WAS FOUND TO BE LEAKING. THE TUBE WAS REMOVED ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16631865 ↗
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- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.