E-PACK 9570ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705031234311), received between Nov 27, 2019 and Oct 31, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WAS CHECKED AND FOUND LEAKING BEFORE INTUBATION, SO IT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036936 ↗
• MalfunctionJun 5, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE WAS FOUND RUPTURED IN INSPECTION DURING PREPARATION FOR INTUBATION. THE TUBE HAS BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061013 ↗
• MalfunctionJun 23, 2021Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, 5-10 ML OF GAS WAS INJECTED TO THE DEVICE BEFORE THE INTUBATION TO TEST THE INTEGRITY OF THE SLEEVE AND CHECK FOR NO AIR LEAKAGE. AFTER INTUBATION THROUGH THE PATIENT NOSE AND THEN INJECTION OF GAS INFLATORS, LEAKAGE WAS FOUND. AFTER PULLING THE TUBE, THE CUFF WAS FOUND BROKEN AND COULD NOT BE INFLATED. THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 12051145 ↗
• MalfunctionMar 23, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, A BRONCHOSCOPY GUIDED TRANSNASAL ENDOTRACHEAL INTUBATION WAS PERFORMED TO ASSIST VENTILATION. THE PACKAGE OF THE ENDOTRACHEAL TUBE WAS UNPACKED, THE BALLOON WAS CHECKED AND THE BALLOON WAS FOUND TO BE LEAKING, AND THE ENDOTRACHEAL TUBE WAS REPLACED IMMEDIATELY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556163 ↗
• MalfunctionMar 20, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE FOUND AIR LEAKAGE. THE DOCTOR IMMEDIATELY REPLACED THE DEVICE AND SUCCESSFULLY COMPLETED THE TREATMENT FOR THE PATIENT. INTUBATION THROUGH ORAL OR NASAL WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9859808 ↗
• MalfunctionNov 27, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE TO THE PATIENT, THE DEVICE'S BALLOON COULD NOT BE INFLATED NORMALLY WHEN TESTING TUBE BEFORE ENDOTRACHEAL INTUBATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9381346 ↗