RUSCH IPN041426Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704341105), received between May 7, 2026 and May 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Deflation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (K931163); 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.

Recalls naming this device

1. May 25, 2023Open, Classified

   Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

   Z-1947-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Unintended Deflation

  IT WAS REPORTED THAT "CUFF DID NOT HOLD AIR WHEN IN PLACE IN THE TRACHEA. DEFLATED WHEN IN PLACE - SECOND ETT USED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K931163. One submission often covers many models, so check the product and lot details in each record.

• Z-1949-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
• Z-1944-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055
• Z-1940-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035
• Z-1950-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
• Z-1942-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780045
• Z-1877-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075
• Z-1945-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060
• Z-1941-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
• Z-1943-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050
• Z-1948-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
• Z-1946-2023 · May 25, 2023 · Open, Classified
  Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065