RUSCH IPN040969Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 14026704340962), received between Apr 6, 2021 and Dec 7, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K990619); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND CUFF LEAKAGE BEFORE USING ON PATIENT WHEN IN A CLINICAL SETTING BEFORE USING ON PATIENT. IT WAS CHANGED TO A NEW ONE. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934212 ↗
• MalfunctionNov 7, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED ON (B)(6) 2022 THAT THE DOCTOR FOUND THE CUFF TO BE LEAKING BEFORE USE ON A PATIENT. A NEW DEVICE WAS CHANGED. THERE WAS NO IMPACT ON THE PATIENT. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744814 ↗
• MalfunctionNov 11, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "DOCTOR OPENED THE PRODUCT AND PUT AIR IN IT UP TO 40CC. AFTER THEN, FOUND LEAKAGE ON BALLOON". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798725 ↗
• MalfunctionJun 23, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING THE OPERATION AND TRIED 2 TIMES TO USE SAME LOT OF PRODUCT BUT FOUND SAME ISSUE ON PRODUCTS, THE PATIENT STATUS IS UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053462 ↗
• MalfunctionJun 23, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE CUFF LEAKING DURING THE OPERATION AND TRIED 2 TIMES TO USE THE SAME LOT OF PRODUCT BUT FOUND THE SAME ISSUE ON PRODUCTS, THE PATIENT STATUS IS UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053404 ↗
• MalfunctionJun 23, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE CUFF LEAKING DURING THE OPERATION AND TRIED TO USE THE SAME LOT OF PRODUCT BUT FOUND SAME ISSUE ON THE PRODUCT, THE PATIENT STATUS IS UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053364 ↗
• MalfunctionJun 23, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE CUFF LEAKING DURING THE OPERATION AND TRIED TO USE THE SAME LOT OF PRODUCT BUT FOUND SAME ISSUE ON THE PRODUCT, THE PATIENT STATUS IS UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053332 ↗
• MalfunctionApr 6, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "BEFORE USE TO PATIENT RUSCH ETT NO 7, DOCTOR TESTING FIRST BY INFLATE THE BALLOON 7CC, BUT THE BALLOON ETT DEFLATED BY SELF, SO THE ETT WAS CHANGE WITH THE NEW ETT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619728 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990619. One submission often covers many models, so check the product and lot details in each record.

• Z-1124-2015 · Dec 12, 2014 · Terminated
  RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be