Medline Industries DYND70320Recalls & reported problems
Medline Industries, Inc. · TUBE,GASTROSTOMY,20FR,3-PORT,WHITE,1/CS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196837922), received between Dec 11, 2018 and Sep 25, 2026 — classified as 1 injury, 7 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
- Burst Container or Vessel1
- Device Dislodged or Dislocated1
- Fluid/Blood Leak1
- Material Rupture1
- Material Split, Cut or Torn1
- Unintended Deflation1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902779 ↗InjuryNov 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE TUBE IS "EASILY TEARING APART" AND "LEAKS ON THE PORT".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18233671 ↗MalfunctionNov 2, 2020Device Dislodged or Dislocated; Unintended Deflation
THE PATIENT'S GASTROSTOMY TUBE DEFLATED WHILE STILL INSERTED AND FELL OUT REQUIRING INSERTION OF A NEW GASTROSTOMY TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10774623 ↗MalfunctionJun 7, 2019Burst Container or Vessel
IT WAS REPORTED THAT THE GASTROSTOMY TUBE BALLOON BURST AND WAS REQUIRED TO BE REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8678748 ↗MalfunctionJun 7, 2019Material Rupture
IT WAS REPORTED THAT THE GASTROSTOMY TUBE BALLOON BURST AND WAS REQUIRED TO BE REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8678642 ↗MalfunctionJan 7, 2019Break
IT WAS REPORTED THAT THE GASTROSTOMY TUBE'S BALLOON BROKE AND WAS SUBSEQUENTLY REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8221854 ↗MalfunctionDec 11, 2018Deflation Problem
IT WAS REPORTED THAT THE GASTROSTOMY TUBE'S BALLOON DEFLATED AFTER INSERTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8150473 ↗MalfunctionDec 11, 2018Deflation Problem
IT WAS REPORTED THAT THE GASTROSTOMY TUBE'S BALLOON DEFLATED AFTER INSERTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8150394 ↗
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- 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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