Medline Industries DYND70316Recalls & reported problems
Medline Industries, Inc. · TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/CS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196837892), received between Dec 13, 2017 and Jan 18, 2024 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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. 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
- Deflation Problem2
- Break1
- Device Dislodged or Dislocated1
- Leak/Splash1
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2024Deflation Problem; Deflation Problem
InjuryAug 16, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON 7/14 "THE G TUBE PORT BROKE AFTER A MONTH REQUIRING THE G TUBE TO BE REPLACED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17556996 ↗InjuryJul 11, 2023Break; Break
ACCORDING TO THE CUSTOMER, THE GASTROSTOMY TUBE "CRACKED ON THE TOP WHERE IT WAS LEAKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17301458 ↗MalfunctionMay 13, 2019Device Dislodged or Dislocated
IT WAS REPORTED THAT AN UNKNOWN NUMBER OF INCIDENTS OCCURRED WHEREIN GASTROSTOMY TUBES WERE COMING OUT FROM PATIENTS. A PATIENT REPORTEDLY HAD TO BE SENT TO THE HOSPITAL TO HAVE A NEW GASTROSTOMY TUBE PUT IN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8603624 ↗MalfunctionMar 15, 2019Deflation Problem
IT WAS REPORTED THAT THE GASTROSTOMY TUBE'S BALLOONS WERE DEFLATING RESULTING IN THE GASTROSTOMY TUBES FALLING OUT FROM THE PATIENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8424332 ↗InjuryDec 13, 2017Leak/Splash
IT WAS REPORTED A GASTROSTOMY TUBE LEAKED AND HAD TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7112582 ↗
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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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