CovidienRecalls & reported problems across all models
Cardinal Health, Inc. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 7 models of Covidien by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2021 and Jun 8, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Covidien problems
Device problems
- Unintended Deflation34
- Fluid/Blood Leak16
- Break5
- Deflation Problem2
- Material Rupture2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Purulent Discharge1
- Skin Inflammation/ Irritation1
- Unintended Extubation1
Covidien models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Covidien 8884715122ETubes, gastrointestinal (and accessories)15 reports
- Covidien 8884715148EGastrointestinal Tubes with Enteral Specific Connectors11 reports
- Covidien 8884720205ETubes, gastrointestinal (and accessories)11 reports
- Covidien 8884720247EGastrointestinal Tubes with Enteral Specific Connectors7 reports
- Covidien 8884720221ETubes, gastrointestinal (and accessories)6 reports
- Covidien 8884720163EGastrointestinal Tubes with Enteral Specific Connectors2 reports
- Covidien 8884720189ETubes, gastrointestinal (and accessories)2 reports
Recent Covidien adverse event reports
The 15 most recent reports across all models, 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 29, 2026Unintended Deflation
THE CUSTOMER REPORTED THE EXCHANGE WAS CARRIED OUT AND AFTER 5 DAYS THE BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028381 ↗MalfunctionApr 29, 2026Unintended Deflation
THE CUSTOMER REPORTED ONE DAY AFTER THE PROBE WAS INSERTED, IT BECAME EXTERNALIZED. UPON INFLATING THE BALLOON, IT WAS RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028144 ↗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 ↗MalfunctionNov 20, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED A G-TUBE DISLODGMENT DUE TO THE BULB DEFLATING. NURSING BELIEVES THE G-TUBE BULB HAS A LEAK WHICH IS CAUSING THE G-TUBE BULB TO DEFLATE AND LEADING TO DISLODGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610488 ↗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 ↗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 ↗MalfunctionOct 15, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED COMPLETE DISPLACEMENT OF THE GASTROSTOMY TUBE WAS EVIDENT. UPON DISCHARGE, THE INTERNAL RETENTION BALLOON WAS OBSERVED TO BE DEFLATED, WHICH COULD HAVE FACILITATED ITS ACCIDENTAL DISLODGEMENT. THE PATIENT WAS TAKEN TO SURGERY WITH APPROPRIATE MANAGEMENT AND REMAINS IN THE ICU.
Patient problems: Insufficient Information
MAUDE report 23294551 ↗MalfunctionAug 15, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT DURING VITAL SIGNS IT WAS NOTED THAT THE PATIENT'S GASTROSTOMY TUBE WAS DISPLACED/OUTSIDE WHICH WAS REPORTED TO THE SUPERVISOR AND THE ON-DUTY DOCTOR. SUBSEQUENTLY, A CALL WAS MADE TO THE ON-DUTY SURGEON WHO REVIEWED AND PERFORMED A DEVICE CHANGE. THEY STATED THAT THE GASTROSTOMY BALLOON WAS CRYSTALLIZED CAUSING IT TO BE DISPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816165 ↗MalfunctionAug 14, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT BULBS ARE DEFLATING BECAUSE OF HOLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22812562 ↗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 ↗MalfunctionJul 10, 2025Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT THE PATIENT WHO WAS IN THE PEDIATRIC ICU HAD A GASTRONOMY TUBE PLACED ON (B)(6) 2025, AND ON (B)(6) 2025 THE BALLOON OF THE TUBE WAS BROKEN, AND GASTRIC CONTENTS WERE COMING OUT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22475811 ↗
Other Cardinal Health, Inc. products
All Cardinal Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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