RUSCH IPN042742Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704319589), received between Jun 28, 2023 and Jun 28, 2023 — classified as 1 injury.

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

2 FDA recall records name this device's identifier, 2 still open.

26 other recalls cover devices cleared under the same FDA submission (K780900); 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-1832-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 8, 2022Open, Classified

   Potential for pilot balloon non-inflation or cuff non-deflation.

   Z-1010-2023 · Root cause: Process control · 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.

• InjuryJun 28, 2023Disconnection; Disconnection

  IT WAS REPORTED VIA A MEDWATCH REPORT, "THE 15MM BVM (BAG-VALVE MASK) ADAPTER ON THE ET TUBE (ENDOTRACHEAL) TUBE CAME OFF OF THE TUBE AND WOULD NOT STAY IN PLACE AFTER THE PATIENT WAS INTUBATED". ADDITIONAL INFORMATION RECEIVED STATES THAT "MINOR DESATURATION WAS NOTED WITH THIS PATIENT DUE TO ADAPTER COMING OFF, BUT ONLY BY A COUPLE OF POINTS. THE PATIENT DIED SHORTLY AFTER ARRIVING AT THE EMERGENCY DEPARTMENT DUE TO THE EXTERNAL PACER BEING REMOVED. NOT SURE AS TO WHY BUT TO OUR BEST KNOWLEDGE THIS WAS NOT A RESULT OF THE ET TUBE". FURTHER QUESTIONS WERE ASKED REGARDING THE CAUSE AND CIRCUMSTANCES OF THE PATIENT'S DEATH BUT THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY FURTHER INFORMATION. IF INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17217930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780900. One submission often covers many models, so check the product and lot details in each record.

• Z-1828-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
• Z-1841-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
• Z-1843-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150
• Z-1831-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070
• Z-1904-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040
• Z-1902-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030
• Z-1834-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
• Z-1829-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
• Z-1827-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
• Z-1842-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
• Z-1901-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025
• Z-1905-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
• Z-1903-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035
• Z-1837-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
• Z-1836-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095

…and 11 more.