Medline Industries, Inc. DYND43075Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10080196726325), received between Oct 31, 2018 and Sep 14, 2026 — classified as 1 death, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K042683); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Deflation Problem; Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762982 ↗
• InjuryAug 13, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, THE ENDOTRACHEAL TUBE PILOT BALLOON WAS "NOT INFLATING AND THE CUFF AT THE END IS NOT HOLDING PRESSURE" WHILE THE PATIENT WAS ON A VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977198 ↗
• InjuryAug 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE "PILOT BALLOON WOULD NOT REMAIN INFLATED."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19961699 ↗
• InjuryAug 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE "PILOT BALLOON WOULD NOT REMAIN INFLATED".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19961047 ↗
• InjuryJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AFTER INSERTION OF THE TRACH TUBE, IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING TIDAL VOLUMES

  Patient problems: Insufficient Information

  MAUDE report 19598755 ↗
• InjuryJun 11, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE CUSTOMER, THE PATIENT WAS REQUIRING INTUBATION DURING A "CODE BLUE" ON (B)(6) 2024 AND THE "ETT" CUFF WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509932 ↗
• InjuryJan 30, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  "THE TIP OF THE TUBE IS SHARP AND STIFF."

  Patient problems: Insufficient Information

  MAUDE report 18605466 ↗
• InjuryApr 25, 2023Pressure Problem; Pressure Problem

  PILOT BALLOON NOT MAINTAINING PRESSURE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 16808134 ↗
• MalfunctionJun 15, 2022Gas/Air Leak

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, WHEN THE PATIENT WAS ALREADY INTUBATED, THE FACILITY NOTICED A LOW RETURN VOLUME AND AN AUDIBLE CUFF LEAK REQUIRING RE-INTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14696550 ↗
• DeathNov 16, 2021Inflation Problem

  IT WAS REPORTED THAT DURING AN EMERGENT PLACEMENT (DURING AN IN-FLIGHT CARDIAC ARREST) A PATIENT WAS INTUBATED WITH A 7.5MM ENDOTRACHEAL TUBE. INTUBATION WAS COMPLETED AND THE CUFF WAS INFLATED WITH 7ML OF AIR. THE CREW NOTED THAT THE CUFF WOULD NOT STAY INFLATED, BOUGIE WAS PLACED AND THE TUBE WAS EXCHANGED SUCCESSFULLY HOWEVER THE PATIENT ULTIMATELY PASSED AWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12821827 ↗
• MalfunctionOct 31, 2018Particulates

  IT WAS REPORTED THAT A PARTICULATE ORIGINATING FROM THE PACKAGING GOT INSIDE THE ENDOTRACHEAL TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023569 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042683. One submission often covers many models, so check the product and lot details in each record.

• Z-3172-2026 · Jul 31, 2026 · Open, Classified
  SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25