RUSCH IPN040897Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026704002641), received between Mar 30, 2021 and Mar 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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.

• MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "OUTER CUFF SUDDENLY LEAKING, WAS FILLED WITH WATER AS RECOMMENDED. SLOW LEAKAGE FROM THE CUFF PERIOPERATIVELY SOME TIME INTO THE OPERATION. CLINICAL CONSEQUENCES: THE OPERATION WAS UNNECESSARILY PROLONGED". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Fluid Discharge

  MAUDE report 11592157 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "PATIENT: MALE. OUTER CUFF BEGINS LEAKING PERIOPERATIVELY. IT WAS FILLED WITH WATER AS PRESCRIBED. THE CUFF BEGINS LEAKING IN THE MIDDLE OF THE OPERATION. NO EXPLANATION WHEN THE POSITION OF THE TUBE WAS INSPECTED USING VIDEO OPTICS. IT WAS NOT POSSIBLE TO GET THIS SEALED AND IT WAS CHANGED TO A STANDARD TUBE AND THE OPERATION WAS COMPLETED WITHOUT COMPLICATION. CLINICAL CONSEQUENCES: NONE, AS THE EVENT WAS AVOIDED". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Fluid Discharge

  MAUDE report 11592099 ↗

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-1686-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
• Z-1684-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
• Z-1685-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
• Z-1683-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
• Z-1682-2019 · Apr 1, 2019 · Terminated
  RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
• 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