RUSCH IPN042498Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04026704319688), received between Feb 11, 2021 and Dec 5, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

27 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-1904-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: . PLACES LARYNGEAL MASK '4 WHERE THERE IS A LEAK IN THE ANAESTHESIA MACHINE, THE BALLOON IS INFLATED AND AFTER A WHILE IT DEFLATES. THE REPORTED DEFECT WAS DETECTED PRIOR TO USE (IN A CLINICAL SETTING). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265658 ↗
• MalfunctionNov 2, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT"THE CUFF OF PROSEAL #4 DID NOT INFLATE WHEN A NURSE TRIED TO INFLATE IT AFTER INTUBATION". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE". IT WAS REPORTED THAT DEVICE WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738032 ↗
• MalfunctionJul 29, 2021Deflation Problem; Infusion or Flow Problem; Deflation Problem; Infusion or Flow Problem

  IT WAS REPORTED "A BRAND NEW LMA PROSEAL #4 WAS OPENED TO USE FOR INSPECTION/FUNCTIONAL TESTING. THE NURSE AT CLINIC FOUND THE CUFF HAD DIFFICULTY OF DEFLATING/INFLATING. IT SEEMS SOMETHING WRONG WITH ITS RED PLUG". NO PATIENT INVOLVEMENT REPORTED. 2 MDRS SUBMITTED: 9681900-2021-00022 - DIFFICULT TO DEFLATE CUFF ON DEVICE; 9681900-2021-00021 - DIFFICULT TO INFLATE CUFF ON DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246354 ↗
• MalfunctionJul 29, 2021Inflation Problem; Infusion or Flow Problem; Inflation Problem; Infusion or Flow Problem

  IT WAS REPORTED "A BRAND NEW LMA PROSEAL #4 WAS OPENED TO USE FOR INSPECTION/FUNCTIONAL TESTING. THE NURSE AT CLINIC FOUND THE CUFF HAD DIFFICULTY OF DEFLATING/INFLATING. IT SEEMS SOMETHING WRONG WITH ITS RED PLUG". NO PATIENT INVOLVEMENT REPORTED. 2 MDRS SUBMITTED: 9681900-2021-00022 - DIFFICULT TO DEFLATE CUFF ON DEVICE; 9681900-2021-00021 - DIFFICULT TO INFLATE CUFF ON DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246326 ↗
• MalfunctionMay 25, 2021Break; Break

  IT WAS REPORTED "WHEN THE PROSEAL WAS BEING INTRODUCED INTO A PATIENT, THE TUBING SNAPPED OFF AT THE CONNECTOR SITE. PART OF TUBING REMAINED INSIDE CONNECTOR". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881002 ↗
• MalfunctionMay 4, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "THE REAR CUFF OF SERIAL # (B)(4) HAS WRINKLE AND HAS DIFFICULTY OF DEFLATION FROM ITS RED PLUG". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773465 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT "A DOCTOR FOUND THAT AFTER INFLATING THE CUFF, ITS SHAPE WAS NOT SYMMETRICAL". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773437 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT "THE 15MM CONNECTOR WAS COMPLETELY BROKEN. IT HAPPENED WHEN THE NURSE AT HOSPITAL TRIED CONNECTING HME (HEAT MOISTURE EXCHANGER) TO AN ELBOW CONNECTOR (JAPAN MEDICALNEXT/INTERSURGICAL: FIXED ELBOWS 1997000) WHICH WAS CONNECTED TO THE LMA PROSEAL AFTER INTUBATION. THE BROKEN 15MM CONNECTOR WAS DISPOSED". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740625 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND RED PLUG BROKEN BEFORE USE". NO PATIENT INVOLVEMNT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740483 ↗
• MalfunctionFeb 11, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "PILOT CUFF BURST DURING CUFF INVESTIGATION. CLINICAL CONSEQUENCES: NONE AS PRIOR TO USE ON A PATIENT DURING INSPECT ION/FUNCTIONAL TESTING". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317370 ↗

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-1901-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025
• Z-1841-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
• Z-1833-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
• Z-1900-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020
• Z-1897-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
• Z-1827-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
• Z-1835-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
• Z-1839-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130
• Z-1837-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
• Z-1838-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125
• Z-1844-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155
• Z-1840-2023 · May 25, 2023 · Open, Classified
  Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
• Z-1860-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100
• Z-1832-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
• Z-1831-2023 · May 25, 2023 · Open, Classified
  Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070

…and 12 more.