Medline Industries DYND70318Recalls & reported problems
Medline Industries, Inc. · TUBE,GASTROSTOMY,18FR,3-PORT,WHITE,1/CS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10080196837908), received between Jan 30, 2018 and Sep 29, 2026 — classified as 4 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 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
- Material Rupture4
- Break2
- Deflation Problem2
- Fluid/Blood Leak2
- Material Split, Cut or Torn2
- Burst Container or Vessel1
- Device Fell1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933110 ↗MalfunctionSep 29, 2026Break; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933089 ↗InjuryOct 15, 2025Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 AFTER A "G-TUBE PLACEMENT" THE TUBE HAD "FALLEN OUT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291154 ↗InjuryOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE FACILITY "THE G-TUBE FELL OUT OF THE PATIENT WHILE SHE TOOK A DEEP BREATH".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290328 ↗MalfunctionJan 13, 2021Leak/Splash
IT IS REPORTED; THE BALLOON LEAKED RESULTING IN A GASTROSTOMY TUBE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11166869 ↗MalfunctionOct 21, 2019Gas/Air Leak; Device Fell
IT WAS REPORTED BY THE FACILITY THAT THE BALLOON IN THE GASTROSTOMY TUBE DEFLATED AND THE GASTROSTOMY TUBE FELL OUT OF THE PATIENT REQUIRING THE GASTROSTOMY TUBE TO BE REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9213246 ↗MalfunctionOct 21, 2019Deflation Problem
IT WAS REPORTED BY THE FACILITY THAT BALLOON IN THE GASTROSTOMY TUBE DEFLATED AND GASTROSTOMY TUBE FELL OUT OF THE PATIENT REQUIRING THE GASTROSTOMY TUBE TO BE REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9213160 ↗MalfunctionJul 22, 2019Material Rupture
IT WAS REPORTED THAT THE GASTROSTOMY TUBE (G-TUBE) BALLOON "POPPED" AND THE G-TUBE WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8811385 ↗MalfunctionJul 19, 2019Material Rupture
IT WAS REPORTED THAT THE GASTROSTOMY TUBE (G-TUBE) BALLOON "POPPED" AND THE G-TUBE WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8807658 ↗MalfunctionJul 3, 2019Material Split, Cut or Torn
IT WAS REPORTED THAT A TEAR IN THE GASTROSTOMY TUBE (G-TUBE) WAS IDENTIFIED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8758244 ↗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 8678835 ↗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 8678579 ↗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 8424508 ↗InjuryJan 31, 2018Loose or Intermittent Connection
GASTROSTOMY TUBE CAP DOES NOT SECURE DURING PATIENT USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7230501 ↗InjuryJan 30, 2018Device Operates Differently Than Expected
GASTROSTOMY TUBE CAP DOES NOT SECURE DURING PATIENT USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7229351 ↗
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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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