Covidien 8884720247ERecalls & reported problems
Cardinal Health, Inc. · True content to be populated as part of rebranding · Class 2 · Implant
All models of Covidien (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521661738), received between Oct 23, 2024 and Jun 8, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Unintended Deflation
THE CUSTOMER REPORTED WHEN INFLATING THE FIXING BALLOON, LEAKAGE WAS OBSERVED. PER ADDITIONAL INFORMATION PROVIDED, THE DOCTOR INDICATED THAT THE LEAKAGE WAS COMING FROM THE BALLOON. THE ISSUE OCCURRED AFTER INSERTION INTO THE PATIENT. THE TUBE WAS REMOVED AND REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25432660 ↗MalfunctionMay 14, 2026Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON RUPTURED AFTER THE CHANGE. THE NURSE CHANGED THE CATHETER, AND WHEN THE PATIENT WENT TO SHOWER, SHE NOTICED THAT THE CATHETER HAD COME OUT. THE TEAM THEN NOTICED THAT THE BALLOON HAD RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172031 ↗MalfunctionApr 16, 2026Unintended Deflation
THE CUSTOMER REPORTED THEIR CLIENT TOLD THEM THAT THE GASTROSTOMY TUBE BALLOON DEFLATES AND THE BALLOON HAS TO BE FILLED CONSTANTLY. THE FOOD COMES OUT ON SEVERAL OCCASIONS AS A RESULT OF WHAT HAPPENED. PER ADDITIONAL INFORMATION RECEIVED, THE AFFECTED G-TUBE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. AS REPORTED: SOLICITO DE SU APOYO DE URGENCIA, YA QUE CLIENTE NOS COMENTO QUE DE LA SONDA DE GASTROSTOMÍA DE CÓDIGO 8884720247E EL GLOBO SE DESINFLA Y SE TIENE QUE ESTAR LLENANDO EL GLOBO CONSTANTEMENTE. LA COMIDA SE SALE EN VARIAS OCASIONES POR CONSECUENCIA DE LO SUCEDIDO. ENGLISH TRANSLATION: I REQUEST YOUR EMERGENCY SUPPORT, SINCE THE CLIENT TOLD US THAT FROM THE GASTROSTOMY TUBE CODE 8884720247E THE BALLOON DEFLATES AND THE BALLOON HAS TO BE FILLED CONSTANTLY. THE FOOD COMES OUT ON SEVERAL OCCASIONS AS A RESULT OF WHAT HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895826 ↗MalfunctionFeb 25, 2026Unintended Deflation
THE CUSTOMER REPORTED WHEN TRYING TO FILL THE BALLOON WITH 15CC OF STERILE WATER, IT WAS FOUND TO HAVE A LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445270 ↗MalfunctionOct 15, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED WHEN THE TUBE WAS PLACED AND INSERTED, THE BALLOON BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301046 ↗MalfunctionJun 2, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT A HOLE IN THE BALLOON OF THE KANGAROO REPLACEMENT PROBE WAS OBSERVED. THERE WAS NO REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22126444 ↗MalfunctionOct 23, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED GASTROSTOMY TUBE PLACEMENT IS PERFORMED FOR REPLACEMENT NO. 24, AFTER THIS, IT IS INDICATED BY EMERGENCY MEDICAL AND NURSING PERSONNEL TO EXIT THE TUBE. IT IS ASSESSED AGAIN WHERE THE BALLOON IS FILLED WITH WATER AND WATER LEAKAGE WAS OBSERVED THROUGH IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516270 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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