RUSCH IPN040898Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026704002658), received between Mar 30, 2021 and Oct 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K935842); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: "DURING USE THE PROXIMAL PORTION OF THE TUBE FOLDED, ALMOST AT RIGHT ANGLES, IN THE MOUNT OF THE PATIENT, WITH BOTH THE CUFFS BETWEEN THE VOCAL CORDS, MAKING IMPOSSIBLE VENTILATION FLOW." ADDITIONAL INFORMATION RECEIVED STATED THAT "NO DESATURATION OR CLINICAL COMPLICATION FOR THE PATIENT. THEY SOLVED THE ISSUE USING ANOTHER LASER TUBE". PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693263 ↗
• MalfunctionMar 30, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "PATIENT DID NOT SATURATE CORRECTLY BECAUSE THE TUBE HAD A LEAKAGE. THE TUBE WAS RETIRED FROM THE PATIENT AND USING ANOTHER TUBE". NO REPORTS OF PATIENT INJURY OR HARM. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K935842. One submission often covers many models, so check the product and lot details in each record.

• Z-2533-2020 · May 29, 2020 · Terminated
  RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D
• Z-1685-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
• Z-1684-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
• Z-1682-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
• Z-1683-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
• Z-1686-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
• Z-1851-2014 · May 23, 2014 · Terminated
  RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the n