Covidien 8884720205ERecalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521661714), received between Jul 24, 2024 and Nov 17, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (11 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 Deflation11
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THEY HAVE HAD MULTIPLE G-TUBE DISLODGEMENTS PERTAINING TO BULBS THAT WERE DEFLATED. THEIR NURSES BELIEVE THE G-TUBE BULB HAS A LEAK WHICH IS CAUSING THE G-TUBE BULB TO DEFLATE AND LEADING TO DISLODGMENT OF THE G-TUBE. NO FURTHER DETAILS ARE AVAILABLE REGARDING EACH INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569295 ↗MalfunctionAug 14, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT TWO DEVICES HAVE HOLES ON THE BULB. ON (B)(6) 2025 THE INITIAL REPORTER CONFIRMED THE ISSUE WAS WITH THE BALLOON AND OCCURRED DU RING PATIENT USE. NO HARM NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22812405 ↗MalfunctionJul 21, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THEY ATTEMPTED TO DEFLATE THE BALLOON; HOWEVER, THERE IS NO WATER BACKFLOW. THEY ATTEMPTED TO RE-INFLATE THE BALLOON WITH 20 ML OF STERILE WATER, AND THEN DEFLATE THE BALLOON, BUT NO WATER BACKFLOW AND APPROXIMATELY 5 ML OF A FOAMY WHITISH GASTRIC FLUID IS PRESENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE BALLOON WAS RUPTURED AND THE DEVICE WAS COMING OUT OF THE GASTROSTOMY INSERTION SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553734 ↗MalfunctionJun 10, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT A BALLOON TEST WAS PERFORMED WITH 20ML OF DISTILLED WATER AND THE BALLOON SHOWED DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22180839 ↗MalfunctionJan 29, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE PATIENT WAS SCHEDULED FOR AN OPEN GLOSSECTOMY PLUS GASTROSTOMY TUBE PLACEMENT AND WHEN PERFORMING GASTROSTOMY TUBE PLACEMENT CX SURGEON DR. (B)(6) PERFORMED BALLOON PERMEABILIZATION AND IT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21264703 ↗MalfunctionJan 13, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE DEVICE CUFF BURST BEFORE 30 D OF INSTALLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137989 ↗MalfunctionNov 27, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE BALLOON OF THE PROBE WAS BROKEN AT THE TIP, PRESENTING LEAKAGE OF DISTILLED WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20796416 ↗MalfunctionNov 20, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED POSSIBLE QUALITY FAILURE OF THE GASTROSTOMY TUBE #20, WHICH COMES OUT OF THE SITE DUE TO BALLOON FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737384 ↗MalfunctionSep 9, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE TUBE WAS PLACED ON (B)(6) 2024 AND FAILED LESS THAN 24 HOURS LATER. THE BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20171251 ↗MalfunctionJul 24, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON OF THE TUBE RUPTURED 4 WEEKS AFTER PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED, THE TUBE HAD TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817503 ↗MalfunctionJul 24, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON OF THE TUBE RUPTURED 4 WEEKS AFTER PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED, THE TUBE HAD TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817497 ↗
Other Tubes, gastrointestinal (and accessories) devices
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- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
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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