RUSCH IPN041707Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704344298), received between Jul 10, 2023 and Sep 19, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE HEALTH CARE FACILITY THAT: "THE TIP (LUG) OF THE CARLENS 41 TUBE WAS AGAINST THE BALLOON AND DID NOT DEPLOY DURING INTUBATION, EVEN WITH THE BRONCHIAL FIBERSCOPE."

  Patient problems: Insufficient Information

  MAUDE report 23094002 ↗
• InjuryNov 25, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT "THE INCIDENT OCCURRED DURING EXTUBATION. AFTER DEFLATING BOTH BALLOONS (WITH BOTH PILOT BALLOONS DEFLATED) THE TRACHEAL BALLOON WAS STILL INFLATED. BOTH BALLOONS HAD BLOOD ON THEM". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20771984 ↗
• InjuryJul 10, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A THORACIC SURGERY, THE BRONCHIAL CUFF DEFLATED, EVEN AFTER RE-INFLATING THE CUFF. THE CUFF HAD BEEN PRETESTED PRIOR TO A SUCCESSFUL INTUBATION FOR A THORACIC SURGERY. AFTER THE DEFLATION WAS DISCOVERED DURING SURGERY, CONTINUOUS MONITORING OF THE CUFF PRESSURE WAS PERFORMED AND REGULAR RE-INFLATION WAS PERFORMED TO MAINTAIN PRESSURE OF THE CUFF. AS A RESULT, "THERE WAS POOR VENTILATION OF THE PATIENT DURING THE PROCEDURE DUE TO THE LACK OF SEALING OF THE CUFF". ADDITIONAL INFORMATION RECEIVED STATES THAT THE "PATIENT FACED OCCASIONAL AND RECURRENT DESATURATIONS RELATED TO VENTILATORY DIFFICULTIES. HOWEVER, NO OTHER MAJOR CLINICAL CONSEQUENCE FOR THE PATIENT". THERE WAS NO INFORMATION PROVIDED ON THE OXYGEN SATURATION PERCENTAGES THAT THE PATIENT EXPERIENCED. THE CURRENT STATUS OF THE PATIENT IS REPORTED AS "POST-OPERATIVE FOLLOW UP WITHOUT ANYTHING SPECIAL FOR THE CURRENT CONDITION".

  Patient problems: Low Oxygen Saturation

  MAUDE report 17293824 ↗